The document discusses various sources of impurities in pharmaceuticals such as raw materials, reagents, manufacturing processes, storage conditions, and defines an impurity as any undesired substance that affects the purity of the material. It explains the effects of impurities including toxicity, decreased potency, and incompatibility with other substances. Tests for purity are prescribed by pharmacopoeias to ensure freedom from undesirable impurities and establish limits of tolerance for common impurities.
This document discusses astringents and their properties. It provides information on zinc sulfate and potash alum, including their formulas, preparation methods, properties, assay methods, and common uses. Zinc sulfate and potash alum are both used as astringents to constrict tissues and stop bleeding from minor wounds. They are also used as nutritional supplements or in water treatment processes.
DEFINATION
TYPES OF COUGH
CLASSIFICATION OF EXPECTORANT AND MECHANISM OF ACTION
DEFINATION OF EMETICS
MECHANISM OF ACTION OF EMETICS
COMPOUND RELATED TO EXPECTORANT.
This document discusses pharmaceutical impurities. It defines impurity as unwanted foreign particles other than the active drug. Impurities can come from raw materials, reagents, manufacturing processes, storage conditions, or deliberate adulteration. The types and amounts of impurities depend on factors like purity of starting materials and purification methods. Limit tests are used to detect and limit specific impurities like chlorides, sulphates, and iron according to pharmacopeia limits. The tests use reactions like precipitation or color changes to compare a sample to a standard of a known impurity level. Maintaining low impurity levels is important for safety, efficacy, and stability of pharmaceutical products.
Expectorants are agents that enhance sputum secretion from the respiratory tract and facilitate removal of bronchopulmonary mucus. They are classified as sedatives like ipecac or stimulants like eucalyptus oil. Potassium iodide is a sedative expectorant prepared by reacting iodine with potassium hydroxide or using iron fillings with potassium carbonate. Ammonium chloride is also a sedative expectorant made by neutralizing hydrochloric acid with ammonia. Emetics induce vomiting by stimulating the chemoreceptor trigger zone or irritating the GI tract. Copper sulphate is a common emetic that is prepared as blue crystals through a two-
The document provides information on the preparation, properties, assays, and uses of several inorganic compounds including sodium chloride, calcium gluconate, ammonium chloride, sodium bicarbonate, hydrogen peroxide, chlorinated lime, copper sulphate, ferrous sulphate, and sodium thiosulphate. For each compound, methods of preparation, physical and chemical properties, assay methods (often titration based), and common uses are described. The compounds discussed are commonly used in pharmaceutical, medical, industrial, and laboratory applications.
This document provides information on various monophasic liquid dosage forms including gargles, mouthwashes, throat paints, and syrups. It discusses the components, advantages, disadvantages, and methods of preparation for each type. Gargles are aqueous solutions used to treat throat infections that are prepared by dissolving ingredients in solvents. Mouthwashes are solutions used for oral hygiene that can be cosmetic or therapeutic. Throat paints are viscous liquids applied to the mouth and throat to treat infections. Syrups are concentrated sugar solutions that can also contain medication, providing a pleasant way to administer liquid drugs. The document outlines the typical ingredients and formulations for each monophasic liquid dosage form.
This document discusses impurities in pharmaceuticals and limit testing. It defines impurity as any undesired material that affects the purity of the substance. Impurities can come from raw materials, reagents, manufacturing processes, storage conditions, or deliberate adulteration. Limit tests are used to check pharmaceuticals for common toxic impurities like arsenic, lead, iron and ensure they are below safe levels. Proper testing of impurities is important to ensure pharmaceuticals are safe and effective.
Emetics are drugs that induce vomiting by causing the contents of the stomach to be expelled through the mouth. They are important for treating poisoning cases. Copper sulfate is a common emetic that is blue crystalline powder. It can be assayed through an oxidation-reduction titration with iodine and sodium thiosulfate. Sodium potassium tartrate, also known as Rochelle salt, is a crystalline powder that is soluble in water. It has uses as a laxative, diuretic, and food additive.
This document discusses astringents and their properties. It provides information on zinc sulfate and potash alum, including their formulas, preparation methods, properties, assay methods, and common uses. Zinc sulfate and potash alum are both used as astringents to constrict tissues and stop bleeding from minor wounds. They are also used as nutritional supplements or in water treatment processes.
DEFINATION
TYPES OF COUGH
CLASSIFICATION OF EXPECTORANT AND MECHANISM OF ACTION
DEFINATION OF EMETICS
MECHANISM OF ACTION OF EMETICS
COMPOUND RELATED TO EXPECTORANT.
This document discusses pharmaceutical impurities. It defines impurity as unwanted foreign particles other than the active drug. Impurities can come from raw materials, reagents, manufacturing processes, storage conditions, or deliberate adulteration. The types and amounts of impurities depend on factors like purity of starting materials and purification methods. Limit tests are used to detect and limit specific impurities like chlorides, sulphates, and iron according to pharmacopeia limits. The tests use reactions like precipitation or color changes to compare a sample to a standard of a known impurity level. Maintaining low impurity levels is important for safety, efficacy, and stability of pharmaceutical products.
Expectorants are agents that enhance sputum secretion from the respiratory tract and facilitate removal of bronchopulmonary mucus. They are classified as sedatives like ipecac or stimulants like eucalyptus oil. Potassium iodide is a sedative expectorant prepared by reacting iodine with potassium hydroxide or using iron fillings with potassium carbonate. Ammonium chloride is also a sedative expectorant made by neutralizing hydrochloric acid with ammonia. Emetics induce vomiting by stimulating the chemoreceptor trigger zone or irritating the GI tract. Copper sulphate is a common emetic that is prepared as blue crystals through a two-
The document provides information on the preparation, properties, assays, and uses of several inorganic compounds including sodium chloride, calcium gluconate, ammonium chloride, sodium bicarbonate, hydrogen peroxide, chlorinated lime, copper sulphate, ferrous sulphate, and sodium thiosulphate. For each compound, methods of preparation, physical and chemical properties, assay methods (often titration based), and common uses are described. The compounds discussed are commonly used in pharmaceutical, medical, industrial, and laboratory applications.
This document provides information on various monophasic liquid dosage forms including gargles, mouthwashes, throat paints, and syrups. It discusses the components, advantages, disadvantages, and methods of preparation for each type. Gargles are aqueous solutions used to treat throat infections that are prepared by dissolving ingredients in solvents. Mouthwashes are solutions used for oral hygiene that can be cosmetic or therapeutic. Throat paints are viscous liquids applied to the mouth and throat to treat infections. Syrups are concentrated sugar solutions that can also contain medication, providing a pleasant way to administer liquid drugs. The document outlines the typical ingredients and formulations for each monophasic liquid dosage form.
This document discusses impurities in pharmaceuticals and limit testing. It defines impurity as any undesired material that affects the purity of the substance. Impurities can come from raw materials, reagents, manufacturing processes, storage conditions, or deliberate adulteration. Limit tests are used to check pharmaceuticals for common toxic impurities like arsenic, lead, iron and ensure they are below safe levels. Proper testing of impurities is important to ensure pharmaceuticals are safe and effective.
Emetics are drugs that induce vomiting by causing the contents of the stomach to be expelled through the mouth. They are important for treating poisoning cases. Copper sulfate is a common emetic that is blue crystalline powder. It can be assayed through an oxidation-reduction titration with iodine and sodium thiosulfate. Sodium potassium tartrate, also known as Rochelle salt, is a crystalline powder that is soluble in water. It has uses as a laxative, diuretic, and food additive.
Impurities can arise from various sources in pharmaceutical preparations including raw materials, equipment, reagents, solvents, and the manufacturing process itself. Raw materials may introduce impurities like heavy metals, chemicals used to eliminate other impurities can become impurities themselves if not removed properly. The equipment, intermediates generated during synthesis, chemical reactions used, and defects in manufacturing can all contribute to impurities being introduced. Proper specifications and analytical procedures are needed to identify, quantify, and limit both known and unknown impurities.
This document discusses the evaluation of semi-solid dosage forms. It defines semi-solids and classifies them into different types including ointments, creams, pastes, poultices, gels, and plasters. It describes the key characteristics and uses of each type. The document also covers important ingredients for semi-solids, including bases, and methods for evaluating different properties of semi-solids like penetration rate, absorption, rheology, biological testing, drug content, viscosity, and spreadability.
Impurities in pharmaceutical substancesTushar Tukre
The document discusses impurities in pharmaceutical substances. It provides a history of pharmacopoeias and their role in setting standards for drugs. It then discusses sources and types of impurities that can arise during the manufacturing, purification, and storage of drugs. Impurities may come from raw materials, reagents, solvents, reaction vessels, intermediate products, or defects in the manufacturing process. The presence of impurities, even in small amounts, can influence the efficacy and safety of pharmaceutical products.
Impurities in pharmaceuticals are the unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and formulated APIs to medicines.
This document discusses sources and types of impurities that may be present in pharmaceutical substances. It identifies several potential sources of impurities including raw materials, manufacturing methods, reaction vessels, atmospheric contamination, and errors in manufacturing or packaging processes. The document also categorizes types of impurities as organic impurities, inorganic impurities, or residual solvents. Organic impurities can arise from starting materials, byproducts, intermediates, or degradation products. Inorganic impurities may come from reagents, ligands, catalysts, metals or other materials. Residual solvents are organic or inorganic liquids used in manufacturing that can remain in the final product.
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Isotopes Types of decay
Alpha rays, which could barely penetrate a piece of paper
Beta rays, which could penetrate 3 mm of aluminium
Gamma rays, which could penetrate several centimetres of lead
Units of Radioactivity:
Measurement of Radioactivity
The measurement of nuclear radiation and detection is an important aspect in the identification of type of radiations (, , ) and to assay the radionuclide emitting the radiation, suitable detectors are required. The radiations are identified on the basis of their properties.
e.g. Ionization effect is measured in Ionization Chamber, Proportional Counter and Geiger Muller Counter.
The scintillation effect of radiation is measured using scintillation detector and the photographic effect is measured by Autoradiography.
Gas Filled Detectors:
Ionization Chamber:
Proportional Counters:
Geiger-Muller Counter
Properties of α, β, γ radiations
Half –life of Radioelement
Sodium Iodide (I131)
Handling and Storage of Radioactive Material:
Storage of Radioactive Substances –
Precautions For Handling Radioactive Substances
Labelling of Radioactive Substances
Pharmaceutical Application Of Radioactive Substances
Semisolid dosage forms: Definitions, classification, mechanisms and factors influencing dermal penetration of drugs. Preparation of ointments, pastes, creams and gels. Excipients used in semi solid dosage forms. Evaluation of semi solid dosages forms
This document discusses various redox titration methods including permanganometry, dichrometry, cerimetry, iodimetry, and bromatometry. It defines oxidation, reduction, and redox reactions. It explains how to calculate equivalent weights of oxidizing and reducing agents and different methods to detect the endpoint of a redox titration including using internal indicators, self indicators, external indicators, and instrumental methods. It provides examples of applications for each type of redox titration.
The document discusses various types of impurities that can be present in pharmaceutical preparations and their sources. It describes six main types of impurities: 1) those that cause toxic or adverse reactions, 2) those that deteriorate the activity of the substance, 3) those that cause incompatibility, 4) those that cause technical problems, 5) those arising from humidity/temperature, and 6) those arising from coloring/flavoring substances. Potential sources of impurities discussed include raw materials, starting materials/reagents, solvents, equipment, intermediates generated during synthesis, and manufacturing defects. Proper control of sources like raw materials, processes, storage conditions, and packaging can help minimize impurities in pharmaceutical preparations.
This is chapter No 3 of Pharmaceutical Chemistry - I for Diploma in Pharmacy (D. Pharmacy) Details notes for Diploma in Pharmacy (D.Pharmacy) Students.
HISTORICAL BACKGROUND & DEVELOPMENT OF PROFESSION OF PHARMACYTeny Thomas
The following presentation deals with what the course of pharmacy is and what a pharmacist is. Also a short brief on the historical growth of the profession of pharmacy when related to education and industry is also discussed here. A detailed view on career in pharmacy is described lastly.
The limit test for iron involves comparing the color produced by reacting a sample containing iron with thioglycollic acid in an alkaline solution to the color produced by a standard iron solution. Citric acid is added to the sample and standard, followed by thioglycollic acid and ammonia. A purple color will develop if iron is present. The intensity of the color in the sample is compared to the standard, and if the sample's color is less than or equal to the standard, it passes the limit test for iron.
Limit tests are quantitative or semi-quantitative tests used to detect and limit small amounts of impurities in substances. They involve comparing the color or turbidity produced by the sample to a standard with a known concentration of impurities. Common limit tests include those for chlorides, sulfates, iron, heavy metals, and arsenic. These tests use chemical reactions to form precipitates or colors whose intensity indicates the concentration of impurities, allowing comparison to a standardized level. Limit tests provide a simple way to check if levels of harmful impurities meet defined specifications.
This document provides information on various types of monophasic liquid dosage forms, including their definitions, advantages, disadvantages, examples, and typical formulation methods. It discusses gargles, mouthwashes, throat paints, ear drops, nasal drops, syrups, elixirs, liniments, and lotions. For each type, it provides a brief description of its use and purpose as well as an example formulation and method.
This document discusses different types of powder dosage forms including their advantages and disadvantages. It describes bulk powders for internal and external use which contain multiple doses of powder in containers. Simple and compound powders for internal use contain individually dosed powders wrapped in paper. Powders can also be enclosed in cachets or capsules. Compressed powders refer to tablets which are made by compressing powder mixtures into flat discs. The document provides examples of different types of powders and details on their preparation and use.
Definition of Impurity
Types of Impurities
Sources of Impurity
foreign unwanted matter present in a compound which are differ from the actual molecular formula.
According to ICH “An impurity in a drug of the new drug substance that is not the substance”.
Chemically a compound is impure if it contains undesirable foreign matter i.e. impurities. Thus chemical purity is freedom from foreign matter
Impurities can have unwanted pharmacological or toxicological effect that seriously impact product quality and patient safety.
The International Conference on Harmonization (ICH) has formulated a workable guideline regarding the control of impurities.
Impurities in pharmaceutical are the unwanted chemicals that remains with the active pharmaceutical ingredient (API’s), or develop during formulation or upon aging of both API and formulated API’s to medicine.
The presence of the unwanted chemicals, even in small amount , may influence the efficacy and safety of pharmaceutical product
The document discusses sources of impurities in pharmaceuticals. Impurities can arise from raw materials, reagents used in manufacturing, the manufacturing process itself, storage conditions, and decomposition over time. Common impurities include heavy metals like arsenic and lead. The presence of impurities can negatively impact safety, efficacy, and shelf life of pharmaceutical products. Pharmacopoeias set limits for common impurities and prescribe tests to evaluate purity.
Impurities can arise from various sources in pharmaceutical preparations including raw materials, equipment, reagents, solvents, and the manufacturing process itself. Raw materials may introduce impurities like heavy metals, chemicals used to eliminate other impurities can become impurities themselves if not removed properly. The equipment, intermediates generated during synthesis, chemical reactions used, and defects in manufacturing can all contribute to impurities being introduced. Proper specifications and analytical procedures are needed to identify, quantify, and limit both known and unknown impurities.
This document discusses the evaluation of semi-solid dosage forms. It defines semi-solids and classifies them into different types including ointments, creams, pastes, poultices, gels, and plasters. It describes the key characteristics and uses of each type. The document also covers important ingredients for semi-solids, including bases, and methods for evaluating different properties of semi-solids like penetration rate, absorption, rheology, biological testing, drug content, viscosity, and spreadability.
Impurities in pharmaceutical substancesTushar Tukre
The document discusses impurities in pharmaceutical substances. It provides a history of pharmacopoeias and their role in setting standards for drugs. It then discusses sources and types of impurities that can arise during the manufacturing, purification, and storage of drugs. Impurities may come from raw materials, reagents, solvents, reaction vessels, intermediate products, or defects in the manufacturing process. The presence of impurities, even in small amounts, can influence the efficacy and safety of pharmaceutical products.
Impurities in pharmaceuticals are the unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and formulated APIs to medicines.
This document discusses sources and types of impurities that may be present in pharmaceutical substances. It identifies several potential sources of impurities including raw materials, manufacturing methods, reaction vessels, atmospheric contamination, and errors in manufacturing or packaging processes. The document also categorizes types of impurities as organic impurities, inorganic impurities, or residual solvents. Organic impurities can arise from starting materials, byproducts, intermediates, or degradation products. Inorganic impurities may come from reagents, ligands, catalysts, metals or other materials. Residual solvents are organic or inorganic liquids used in manufacturing that can remain in the final product.
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Isotopes Types of decay
Alpha rays, which could barely penetrate a piece of paper
Beta rays, which could penetrate 3 mm of aluminium
Gamma rays, which could penetrate several centimetres of lead
Units of Radioactivity:
Measurement of Radioactivity
The measurement of nuclear radiation and detection is an important aspect in the identification of type of radiations (, , ) and to assay the radionuclide emitting the radiation, suitable detectors are required. The radiations are identified on the basis of their properties.
e.g. Ionization effect is measured in Ionization Chamber, Proportional Counter and Geiger Muller Counter.
The scintillation effect of radiation is measured using scintillation detector and the photographic effect is measured by Autoradiography.
Gas Filled Detectors:
Ionization Chamber:
Proportional Counters:
Geiger-Muller Counter
Properties of α, β, γ radiations
Half –life of Radioelement
Sodium Iodide (I131)
Handling and Storage of Radioactive Material:
Storage of Radioactive Substances –
Precautions For Handling Radioactive Substances
Labelling of Radioactive Substances
Pharmaceutical Application Of Radioactive Substances
Semisolid dosage forms: Definitions, classification, mechanisms and factors influencing dermal penetration of drugs. Preparation of ointments, pastes, creams and gels. Excipients used in semi solid dosage forms. Evaluation of semi solid dosages forms
This document discusses various redox titration methods including permanganometry, dichrometry, cerimetry, iodimetry, and bromatometry. It defines oxidation, reduction, and redox reactions. It explains how to calculate equivalent weights of oxidizing and reducing agents and different methods to detect the endpoint of a redox titration including using internal indicators, self indicators, external indicators, and instrumental methods. It provides examples of applications for each type of redox titration.
The document discusses various types of impurities that can be present in pharmaceutical preparations and their sources. It describes six main types of impurities: 1) those that cause toxic or adverse reactions, 2) those that deteriorate the activity of the substance, 3) those that cause incompatibility, 4) those that cause technical problems, 5) those arising from humidity/temperature, and 6) those arising from coloring/flavoring substances. Potential sources of impurities discussed include raw materials, starting materials/reagents, solvents, equipment, intermediates generated during synthesis, and manufacturing defects. Proper control of sources like raw materials, processes, storage conditions, and packaging can help minimize impurities in pharmaceutical preparations.
This is chapter No 3 of Pharmaceutical Chemistry - I for Diploma in Pharmacy (D. Pharmacy) Details notes for Diploma in Pharmacy (D.Pharmacy) Students.
HISTORICAL BACKGROUND & DEVELOPMENT OF PROFESSION OF PHARMACYTeny Thomas
The following presentation deals with what the course of pharmacy is and what a pharmacist is. Also a short brief on the historical growth of the profession of pharmacy when related to education and industry is also discussed here. A detailed view on career in pharmacy is described lastly.
The limit test for iron involves comparing the color produced by reacting a sample containing iron with thioglycollic acid in an alkaline solution to the color produced by a standard iron solution. Citric acid is added to the sample and standard, followed by thioglycollic acid and ammonia. A purple color will develop if iron is present. The intensity of the color in the sample is compared to the standard, and if the sample's color is less than or equal to the standard, it passes the limit test for iron.
Limit tests are quantitative or semi-quantitative tests used to detect and limit small amounts of impurities in substances. They involve comparing the color or turbidity produced by the sample to a standard with a known concentration of impurities. Common limit tests include those for chlorides, sulfates, iron, heavy metals, and arsenic. These tests use chemical reactions to form precipitates or colors whose intensity indicates the concentration of impurities, allowing comparison to a standardized level. Limit tests provide a simple way to check if levels of harmful impurities meet defined specifications.
This document provides information on various types of monophasic liquid dosage forms, including their definitions, advantages, disadvantages, examples, and typical formulation methods. It discusses gargles, mouthwashes, throat paints, ear drops, nasal drops, syrups, elixirs, liniments, and lotions. For each type, it provides a brief description of its use and purpose as well as an example formulation and method.
This document discusses different types of powder dosage forms including their advantages and disadvantages. It describes bulk powders for internal and external use which contain multiple doses of powder in containers. Simple and compound powders for internal use contain individually dosed powders wrapped in paper. Powders can also be enclosed in cachets or capsules. Compressed powders refer to tablets which are made by compressing powder mixtures into flat discs. The document provides examples of different types of powders and details on their preparation and use.
Definition of Impurity
Types of Impurities
Sources of Impurity
foreign unwanted matter present in a compound which are differ from the actual molecular formula.
According to ICH “An impurity in a drug of the new drug substance that is not the substance”.
Chemically a compound is impure if it contains undesirable foreign matter i.e. impurities. Thus chemical purity is freedom from foreign matter
Impurities can have unwanted pharmacological or toxicological effect that seriously impact product quality and patient safety.
The International Conference on Harmonization (ICH) has formulated a workable guideline regarding the control of impurities.
Impurities in pharmaceutical are the unwanted chemicals that remains with the active pharmaceutical ingredient (API’s), or develop during formulation or upon aging of both API and formulated API’s to medicine.
The presence of the unwanted chemicals, even in small amount , may influence the efficacy and safety of pharmaceutical product
The document discusses sources of impurities in pharmaceuticals. Impurities can arise from raw materials, reagents used in manufacturing, the manufacturing process itself, storage conditions, and decomposition over time. Common impurities include heavy metals like arsenic and lead. The presence of impurities can negatively impact safety, efficacy, and shelf life of pharmaceutical products. Pharmacopoeias set limits for common impurities and prescribe tests to evaluate purity.
Types and Sources of impurities.pptx Pharmaceutical Inorganic chemistry UNIT-...Ms. Pooja Bhandare
Types and Sources of impurities. Pharmaceutical Inorganic chemistry UNIT-I (Part-II) Impurities:
Impure Chemical Compound
Pure Chemical Compound.
Types of impurities: Organic Impurity, Inorganic impurity, Residual solvent, Sources of Impurities in Pharmaceuticals
The different sources of impurities in pharmaceuticals are listed below:
Raw material used in manufacture
Reagents used in manufacturing process
Method/ process used in manufacture or method of manufacturing
Chemical processes used in the manufacture
Atmospheric contamination during the manufacturing process
Intermediate products in the manufacturing process
Defects in the manufacturing process
Manufacturing hazards
Inadequate Storage conditions
Decomposition of the product during storage
Accidental substitution or deliberate adulteration with spurious or useless materials.
Test for purity: Pharmacopoeia prescribes the “Test for purity” for pharmaceutical substances to check their freedom from undesirable impurities.
Pharmacopoeia will decide and fix the limit of tolerance for these impurities.
For certain common impurities for which pharmacopoeia prescribes the test of purity are:
Colour, odour, taste
Physicochemical constants (Iodine value, saponification value, melting point, refractive index etc.)
Acidity, alkalinity, pH
Humidity (Estimation of moisture)
Cations and anions
Insoluble Constituent or Residue.
Ash, Water insoluble ash
Arsenic or lead
Loss on drying
Loss on ignition.
Effect of Impurities
Quality control drugs and pharmaceuticalsSHIVANEE VYAS
The term quality control is the most important in pharmaceutical industries. It is essential that a good quality product should be available to the doctors for treating patient or for the actual users. The term quality is applied to drugs and drug products which contributing directly or indirectly to the purity, safety & effectiveness of the products.
1. The document discusses impurities that can be present in pharmaceutical substances, including sources of impurities from raw materials, reagents, manufacturing processes, storage conditions, and other factors.
2. Limit tests are described as quantitative or semi-quantitative tests used to identify and control small amounts of impurities that may be present. Specific examples of limit tests for sulfate, iron, and arsenic are provided.
3. The limit test for iron involves the reaction of iron in an ammonical solution with thioglycollic acid and citric acid to form a ferrous thioglycolate complex, producing a pale pink to deep reddish purple color in an alkaline medium.
Impurities in pharmaceutical substancesShaliniBarad
Impurities definition
Sources of impurities
Effect/ type of impurities
Limit test definition
Limit test Importance,
Principle & procedure of Limit test for iron, chloride, sulphate, arsenic & heavy metals.
This document discusses pharmaceutical impurities, which are unwanted chemicals that remain with active pharmaceutical ingredients or develop during formulation or aging. Impurities can come from raw materials, intermediates, reagents, catalysts, solvents, reaction vessels, improper storage, cross contamination, manufacturing errors, packaging errors, microbial contamination, chemical instability, storage containers, or atmospheric contamination. The presence of impurities can affect the efficacy, safety, and purity of pharmaceutical products. Common impurities include metals, microbes, residual solvents, and degradation products. Strict controls are needed in manufacturing to minimize impurities.
This document discusses quality control and quality assurance in the pharmaceutical industry. Quality control is responsible for sampling, inspecting, testing, and monitoring raw materials, packaging materials, intermediates, and finished products and deciding whether to release or reject them. Quality assurance ensures systems, facilities, procedures, and practices are followed to ensure final products meet specifications. It is responsible for process design, facilities, ventilation, cleanliness, environmental control, validation, and more. Both departments work to maintain high quality standards and minimize impurities that could affect safety, purity, or stability of medicines.
The document discusses sources of impurities in medicinal compounds. It identifies 10 main sources: 1) raw materials, 2) manufacturing methods, 3) reagents, 4) agents used to remove other impurities, 5) solvents, 6) reaction vessels, 7) intermediates, 8) atmospheric contamination, 9) manufacturing hazards, and 10) instability of the product over time. Common impurities from raw materials include heavy metals and other inorganic compounds. The manufacturing process, solvents, and equipment can introduce new impurities. Intermediates may also contaminate the final product if not fully removed.
Define Impurities, 3 Types of Impurities, 13 Sources of Impurities - Raw martials, Reagents used, Methods used, Chemical process, Solvent, Atmospheric contamination, Intermediate process, Defect in manufacturing process, Manufacturing hazards, Impurities due to Storage condition, Impurities due to Crystal packing, Decomposition of product, Adulteration.
The document discusses various types of impurities that may be present in pharmaceuticals and medicinal preparations. It provides examples of different categories of impurities including foreign particles, impurities that cause toxicity, impurities that reduce drug activity, and impurities arising from the manufacturing process, raw materials, or storage conditions. The document also describes tests for purity that are used to identify and limit undesirable impurities according to pharmacopeia standards. Limit tests are discussed as quantitative or semi-quantitative methods to control small amounts of impurities and ensure the purity of pharmaceutical substances.
Organic and inorganic impurities can arise during the manufacturing of drugs from starting materials, byproducts, intermediates, degradation products, reagents, and catalysts used in synthesis. Impurities may also come from defects in manufacturing processes, the solvents, raw materials, and storage conditions used. Proper purification and control of synthesis conditions are needed to minimize impurities and ensure drug safety and efficacy.
Impurities can arise from various sources in pharmaceutical preparations including raw materials, equipment, reagents, solvents, and the manufacturing process itself. Raw materials may introduce impurities like heavy metals or other foreign particles. The equipment, reagents, and solvents used can also lead to impurities if not properly purified or washed. Additionally, the chemical reactions, intermediates, defects in process, and manufacturing hazards have the potential to result in impurities being carried through to the final product. Strict specifications and analytical testing are required to identify, quantify, and limit both known and unknown impurities for safety and efficacy.
This document discusses sources and types of impurities in pharmaceutical substances. It identifies several potential sources of impurities including raw materials, the manufacturing process, solvents, intermediate products, atmospheric contamination, and manufacturing hazards. Long term exposure to impurities can be harmful to the human body, causing issues like respiratory problems, gastrointestinal symptoms, cancer, and more. Careful control and monitoring of the manufacturing process is important to limit impurities in pharmaceutical drugs.
This document discusses impurities in pharmaceutical products. It defines impurities as foreign substances present in small amounts that make a product dirty or unacceptable. Impurities can decrease shelf life, stability, therapeutic effects and increase toxicity. Sources of impurities include synthesis, formulation, storage, particulate matter, byproducts, microbial contamination and heavy metals. The quality and safety of pharmaceuticals is highly dependent on controlling impurities. Proper purification of raw materials and intermediates during synthesis is important to minimize synthesis-related impurities. Storage conditions must be suitable to prevent storage-related impurity formation. Water is a major source of heavy metal impurities so distilled or demineralized water is preferred. Overall, stringent control of all potential sources
Treatment Methodology with Ammonia Recovery of Dyes and Pigment Manufacturing...IRJET Journal
This document reviews treatment methods for wastewater from dyes and pigment manufacturing industries. The wastewater has high levels of chemical oxygen demand (COD), total dissolved solids (TDS), and ammonia-nitrogen (NH3-N). Conventional biological treatment methods are limited in their ability to remove nitrogenous compounds from this wastewater. Advanced treatment methods that allow for ammonia recovery through stripping are discussed. Stripping ammonia at a high pH provides an opportunity to recover ammonia for use in fertilizer production. Coagulation-flocculation using chemicals like sodium hydroxide (NaOH) or calcium hydroxide (Ca(OH)2) to increase pH creates favorable conditions for
INTRODUCTION TO PHARMACEUTICAL CHEMISTRY AND LIMIT TESTSUJATA WANKHEDE
INTRODUCTION TO PHARMACEUTICAL CHEMISTRY, INTRODUCTION TO LIMIT TESTS, LIMIT TEST OF IRON, CHLORIDE, SULPHATE, ARSENIC AND THERE DIAGRAMS WITHTHE PRINCIPAL AND PROCEDURE OF ALL THE LIMIT TEST WITH THEIR RESULTS
Treatment of industrial waste water biological remediation of cyanidesArvind Kumar
This document discusses the treatment of industrial waste water containing cyanides through biological remediation. It provides background information on cyanides, their classification, toxicity, sources in industrial waste streams, and standards for cyanide levels in water. It then summarizes two treatment methods studied - adsorption of cyanides onto activated carbon and their biodegradation by microorganisms. The pathways and various microbes capable of biodegrading cyanides through specific enzymatic reactions are also outlined.
Similar to Pharmaceutical impurity and limit test_by_Raju_Yadav_M.S._Pharm_NIPER_2020 (20)
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
One health condition that is becoming more common day by day is diabetes.
According to research conducted by the National Family Health Survey of India, diabetic cases show a projection which might increase to 10.4% by 2030.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Muscles of Mastication by Dr. Rabia Inam Gandapore.pptx
Pharmaceutical impurity and limit test_by_Raju_Yadav_M.S._Pharm_NIPER_2020
1. Principle of Impurities in Pharmaceuticals
and Limit test
1
Prepared by:Prepared by:
Asst. Prof. Mr. Raju Yadav
M.S. Pharm NIPER
Department of Pharmaceutical Chemistry
Note: If you have any query feel free to contact me:
Mob: +919918575512
Email ID: rajuyadavkip123@gmail.com
2. Outline of the chapter
Definition of impurity
Sources of Impurity
Definition ofAssay
Impurities commonly found in
medicinal preparations
Definition of limit test
Importance of Limit test in pharmaceuticals
Limit test for Iron, Arsenic, Chloride, Lead,
Sulphate, Heavy metals
2
3. Impure Chemical Compound:
A compound is said to be impure if it is having foreign matter i.e Impurities.
Pure Chemical Compound:
A pure chemical compound refers to that compound which is having no foreign matter i.e
impurities.
Chemical purity means freedom from foreign matter.
3
Analytically 100 % pure substances are not available
and traces of impurities must be present.
Normally undesirable foreign materials are present in
the pharmaceutical substances.
4. Impurity means
undesired particles
What is impurity?
Any material that affects the purity of the material of interest.
Presence of Impurities in the pharmaceutical substances may
produce toxic effects on the body and may also lower down
the active strength of the pharmaceuticalsubstance.
Impurities commonly in chemical substances include small
quantities of lead, Arsenic,EsIhra Sohanh , Chloride and sulphate. 44
5. Impurities commonly found in medicinal preparations:
Impurities which have toxic effects on body and bring about unpleasant reactions when
present beyond certain limits. e.g Lead and Arsenic salts.
The impurities which are able to make substance incompatible with other substances.
The impurities which if present beyond the limit, affect the storage property of the
pharmaceuticals.
The impurities which are harmless, but if present beyond the limit, it will lower the The impurities which are harmless, but if present beyond the limit, it will lower the
active strength of the medicinal compound. E.g Sodium salt in potassium salt.
The impurities which may bring about technical difficulties in the use of the substance.
Impurities such as taste, odour, colour or appearance which can be easily detected by the
senses and make the substance unhygienic and unaesthetic. E.g. Sodium chloride becomes
damp because of the presence of traces of magnesium salts. Also phenolic impurities
present in sodium salicylate alters its odour.
5
6. Sources of Impurities in Pharmaceuticals
The type and amount of impurity present in the chemicals or pharmaceutical
substances, depends upon several factors like those listed below:
1) Raw material used in manufacture
2) Reagents used in manufacturing process
3) Method/ process used in manufacture or method of manufacturing
4) Chemical processes used in the manufacture
[GTU important]
6
5) Atmospheric contamination during the manufacturing process
6) Intermediate products in the manufacturing process
7) Defects in the manufacturing process
8) Manufacturing hazards
9) Inadequate Storage conditions
10) Decomposition of the product during storage
11)Accidental substitution or deliberate adulteration with spurious or
useless materials
7. 1) Raw materials employed in manufacture
• Impurities known to be associated with these chemicals may be carried through the
manufacturing process and contaminate the final product.
• Example
Rock salt-------- Calcium Sulphate (CaSO4) + Magnesium Chloride (MgCl2)= NaCl
prepared
Rock salt contains small amounts of Calcium sulphate and Magnesium chloride.
Thus Sodium chloride prepared from this source will contain traces of Calcium
and Magnesium compounds.and Magnesium compounds.
Impurities such as Arsenic, Lead and Heavy metals are present in raw materials
and hence are found in substances. So, it is necessary to use pure chemicals and
substances as raw materials for the manufacturing process.
Calcium sulphate
and Magnesium
chloride
7
8. •Example:
Copper sulphate may be prepared by the action of sulphuric acid on
copper turnings:
Cu+ 2 H2SO4------------------------ CuSO4 + 2 H2O + SO2
Copper turnings are known to have Iron and Arsenic asimpurities.
If Large quantities of impurities are present in the raw material
(e.g Copper turnings), they may enter the final product. (CuSO4.5H2O)
Due to this I.P. prescribes limit of tolerance for Arsenic as impurity to beDue to this I.P. prescribes limit of tolerance for Arsenic as impurity to be
not more than 8 parts per million in copper sulphate. Similarly it
prescribes a limit of Iron as impurity.
Copper turnings 88
9. 2) Reagents used in the manufacturing process:
If reagents used in the manufacturing process are not completely removed by washing,
these may find entry into the final products.
Example:
Ammoniated mercury may be prepared by adding a solution of Mercuric chloride to dilute
ammonia solution.
HgCl2+ 2NH4OH-------------NH2HgCl + NH4Cl + 2 H2O
Soluble soluble Ammoniated mercury (ppt) (soluble)
9
The precipitate of Ammoniated mercury (Final Product)contains ammonium hydroxide.
Thus, this precipitate is washed with cold water to remove ammonium hydroxide.
If it is not removed completely by washing with water, the final product may contain in it
Ammonium hydroxide as impurity.
10. 3) Method or the process used in the
manufacture:
Many drugs and chemicals (usually organic) are manufactured from different raw
materials, by using different methods or processes.
Some impurities are incorporated into the materials during the manufacturing process.
The type and amount of impurity present in the drug/ chemical varies.
In certain drugs , a multiple-step-synthesis procedure is used , which produces
intermediate compounds.
The purification of intermediates is also important, otherwise the impurities present in the
intermediate will get incorporated in the final product.
10
intermediate will get incorporated in the final product.
Usually side reactions occur during the synthesis.
Impurities of the product side reactions also occur in the substances. This may
introduce new impurities due to contamination by reagents and solvents at various
stages of the process as described below:
a) Reagents employed in the process
b) Reagents added to remove other impurities
c) Solvents
d) Action of solvents and reagents on reaction vessels.
11. C) Solvents:
Water is the cheapest solvent available and has been used wherever possible.
Tap Water It has Ca+2, Mg+2, Na+, Cl-, SO -2 and CO -2 as
4 3
impurities in small amounts
Softened water It is obtained by allowing the tap water to pass
through the sodium form of Zeolite which
removes divalent cations like Ca+2 and Mg+2
from tap water in exchange of sodium.
So, softened water contains Na+, Cl- ions as
impurity.
De-mineralised It is obtained by passing tap water throughDe-mineralised
water
It is obtained by passing tap water through
columns packed with ion exchange resin.The
water obtained from this process is free from
Ca+2, Mg+2, Na+, Cl-, SO -2 and CO -2
4 3
Thus the final product is free from these
impurities.
The water obtained from this source may still
contain organic impurities and so final product
contains organic impurities.
Distilled water It is considered the best but it is very costly.
111
1
12. a) Reagents employed in the manufacturing process:
• Soluble alkali in Calcium carbonate arises from sodium carbonate used in the
process.
• Calcium carbonate is obtained by interaction of a soluble calcium salt and a
soluble carbonate and therefore the product will contain traces of soluble alkali,
which the washing process has failed to remove.
b) Reagents added to remove other impurities:
• Potassium bromide contains traces of Barium, which is added in the
manufacturing process to remove excess of sulphate.manufacturing process to remove excess of sulphate.
12
14. d) Action of solvents and reagents on reaction vessels:
During manufacturing process, some of the solvents and reagent may undergo reaction with
metals of reaction vessel and may dissolve these metals, which appear as impurities in the
final product.
Example:
Iron is known to contain Arsenic impurity.
The inorganic compounds manufactured in Iron vessel will contain Arsenic and Iron as
impurities.
Thus IP has prescribed limit test for Arsenic and Iron for most inorganiccompounds.
Iron vessel
14
15. 4) Chemical process used in the manufacture:
For the synthesis of drugs, many chemical reactions such as Nitration, Halogenation,
Oxidation, reduction, hydrolysis are involved.
In these chemical processes, different chemicals are used.
Tap water is generally used in the various processes and it is often having Cl-,Mg+2,
Ca+2 ions, which are generally found in the substance which is being manufactured.
15
16. 5) Atmospheric contamination during the manufacturing
process
In the industrial areas, the atmosphere is contaminated with dust particles and
some gases like Hydrogen sulphide, Sulphur dioxide, and black smoke.
During the manufacture or purification of the pharmaceutical products, these
impurities enter the final products.
There are many pharmaceutical products which when manufactured are
contaminated with atmospheric CO2 and water vapour. E.g NaOH absorbs
atmospheric CO2.
2NaOH + CO2 -------------------------------- Na2CO3 + H2O
Due to this reaction, NaOH should not be kept open for a longer time during its
manufacture.
Therefore, IP has prescribed that Sodium hydroxide should not contain more than
3% of sodium carbonate.
16
17. 6) Defects in the manufacturing process:
In many manufacturing processes, there are defects like imperfect mixing, incompleteness,
non-adherence to proper temperature, pressure, pH or reaction conditions, which may
give chemical compounds with impurities in them.
Example:
• Zinc oxide may be prepared by heating metallic zinc to bright redness in a current of air.
The vapours of Zinc burn to form Zinc oxide which is collected as a fine white powder.
• But if there is less heat or air or both, zinc metal is not completely converted to zinc
oxide.
• Thus the final product, Zinc oxide may still contain metallic zinc as impurity.
17
• Thus the final product, Zinc oxide may still contain metallic zinc as impurity.
• So, IP has prescribed a test for Zinc metal in zinc oxide.
18. 7) Intermediate products in the manufacturing process:
There are some intermediates which are produced during the manufacturing process.
Sometimes these intermediates may be carried through to the final product as impurity.
Example:
Potassium iodide is prepared by reacting Iodine with Potassium hydroxide.
6KOH+ 3I2-------------------- 5KI + KIO3 +3H2O
The resulting solution is first evaporated and then heated with charcoal.
KIO3 + 3C---------- KI + 3CO
18
KIO3 + 3C---------- KI + 3CO
In this process if the intermediate product (KIO3) is not completely converted into KI,
then it may be carried through to the final product as an impurity.
20. Particulate contamination:
The presence of unwanted particulate matter can arise due to dirt, dust, glass,
porcelain or plastic fragments from sieves, granulating or tableting machines or
from product containers.
Ware and tare of equipment or improperly cleaned equipment may also cause
particulate contamination.
Clarity of solutions for injection is particularly important.
E.g Metal particles which have been found in eye ointments packed in metal
tubes.tubes.
20
21. Process errors:
Gross errors arising from incomplete solution of a solute in a liquid preparation must be
detected readily by the normal analytical control procedures.
Minor errors arise if the manufacturing tolerance for the quantity of active ingredient in
the product has been wide.
Cross contamination:
The handling of powders, granules, and tablets in large bulk creates air-borne dust,
which leads to cross contamination of the product.
So, face masks and special extraction equipment are used to protect operators from
harmful effects of drugs.harmful effects of drugs.
E.g penicillin preparation requires special handling during its manufacture.
21
22. Microbial contamination:
• Parenteral preparations and ophthalmic preparations require special care against
microbial contamination.
• Many liquid preparations and creams are liable to bacterial and fungal contamination. So
care should be taken.
• Eg. Acacia, senna, tragacanth---They should be controlled for Salmonellae.
Packing errors:
• Products of similar appearance such as tablets of same size, shape, colour packed in
similar containers can constitute a potential source of danger.
• Improper labelling or destruction of stock of unused labels also constitutes a major
packaging hazard.
22
23. 9) Storage conditions:
The chemical substances when prepared have to be stored in different types of containers
depending upon:
Nature of the material
Batch size
Quantity
Many types of materials are used for storage purpose like plastic, polythene, iron vessels,
stainless steel and aluminium.
The products
Leaching out effect: Alkalies stored in ordinary glass containers extract lead from it,
which in found as impurity in the final product.
Strong chemicals react with iron containers and extract Iron an impurity in final product.
Reaction of these
substances
With materials of
storage vessels
The products
formed are
found as
impurities in the
stored materials
23
24. Inadequate storage and their effects are as follows:
a) Filth: Stored products may become contaminated with dust, bodies of insects, animal and
insect excreta.
b) Chemical instability: decomposition because of light, traces of acid or alkali, air
oxidation, water vapour, CO2 and traces of metallic ions.
e.g light sensitive materials should be stored in amber colored bottles.
c) Reactions with container materials: e.g salicylic acid ointment must not be stored in
metal tubes.
d) Physical changes: The occurance of changes in the physical form of drug like change in
crystal size can lead to change in efficiency of product.
e) Temperature effect: Chemical and physical changes occur if materials are not stored ate) Temperature effect: Chemical and physical changes occur if materials are not stored at
proper temperature.
24
25. 10) Decomposition of the product during storage:
Chemical decomposition, analysis or breakdown is the separation of a chemical
compound into elements or simpler compounds. It is sometimes defined as the exact
opposite of a chemical synthesis. Chemical decomposition is often an undesired chemical
reaction.
Some substances decompose on storing due to presence of air, light and oxygen. So,
the final product is contaminated.
Deliquescent substances, absorb water from the atmosphere and get liquefied.
Decomposition products appear as impurities in the substances.
25
26. 11) Accidental substitution or deliberate adulteration with spurious or
useless materials:
It is possible to avoid accidental substitution by storing the toxic substances together
separately or in a locked cupboard.
Many pharmaceutical chemicals are adulterated with cheaper substances.
E.g The expensive potassium may be adulterated with sodium bromide.
26
27. Effect of Impurities:
The impurities present in the substances may give following effects:
Impurities having toxic effects may be injurious to health, if present above
certain limits.
Traces of impurities, may exert a cumulative toxic effect after a certain time.
Impurities may lower the active strength of the substance.
Impurity may decrease shelf life of substance.
Impurity may cause incompatibility with other substances.
Impurities may cause a physical or chemical change in the properties of the
substance, so making the substance medicinally useless.
May cause change in color, odour and taste.
27
May cause change in color, odour and taste.
28. Test for purity:
Pharmacopoeia prescribes the “Test for purity” for pharmaceutical substances to
check their freedom from undesirable impurities.
Pharmacopoeia will decide and fix the limit of tolerance for these impurities.
For certain common impurities for which pharmacopoeia prescribes the test of
purity are:
Colour, odour, taste
Physicochemical constants (Iodine value, saponification value, melting point,
refractive index etc.)
Acidity, alkalinity, pH
28
Acidity, alkalinity, pH
Humidity (Estimation of moisture)
Cations and anions
Ash
Arsenic or lead
Loss on drying
Loss on ignition
29. Impurity means
undesired particles
What is impurity?
Any material that affects the purity of the material of interest.
Presence of Impurities in the pharmaceutical substances may
produce toxic effects on the body and may also lower down
the active strength of the pharmaceuticalsubstance.
Impurities commonly in chemical substances include small
quantities of lead, Arsenic,EsIhra Sohanh , Chloride and sulphate. 292
9
30. Limit tests:
Tests being used to identify the impurity.
Tests being used to control the impurity.
Definition: Limit tests are quantitative or semi quantitative test
designed to identify and control small quantities of impurities which
are likely to be present in the substances.
30
31. Factors affecting limit tests:
Specificity of the tests
Sensitivity
Control of personal errors (Analyst errors)
• Test in which there is no visible reaction
• Comparison methods
• Quantitative determination
31
32. Types:
Tests in which there is no visible reaction
Comparison methods
Quantitative determinations
32
34. Limit test for IRON:
Limit test of Iron is based on the reaction of iron in ammonical solution with
thioglycollic acid in presence of citric acid to form iron thioglycolate (Ferrous
thioglycolate complex) which produces pale pink to deep reddish purple color in alkaline
media.
Thioglycolic acid is used as reducing agent.
The color of the Ferrous thioglycolate complex fades in the presence of air due to
oxidation.
Also, the color is destroyed in presence of oxidizing agents and strong alkalis.
The purple color is developed only in alkaline media. So ammonia solution is used.
But ammonia reacts with iron, forms precipitate of ferrous hydroxide.
Thus citric acid is used which prevents the precipitate of iron with Ammonia by forming
a complex with iron as iron citrate.
34
35. Test sample Standard compound
Sample is dissolved in specific amount
of water and then volume is made up to
40 ml
2 ml of standard solution of iron diluted
with water upto 40 ml
Add 2 ml of 20 % w/v of citric acid
(iron free)
Add 2 ml of 20 % w/v of citric acid
(iron free)
Add 2 drops of thioglycollic acid Add 2 drops of thioglycollic acid
Procedure:
Add ammonia to make the solution
alkaline and adjust the volume to 50 ml
Add ammonia to make the solution
alkaline and adjust the volume to 50 ml
Keep aside for 5 min Keep aside for 5 min
Color developed is viewed vertically
and compared with standard solution
Color developed is viewed vertically and
compared with standard solution
35
Note: All the reagents used in the limit test for Iron should themselves be iron free.
36. Observation:
The purple color produce in sample solution should not be greater than standard solution. If
purple color produces in sample solution is less than the standard solution, the sample will
pass the limit test of iron and vice versa.
Reasons:
Citric acid forms complex with metal cation and helps precipitation of iron by
ammonia by forming a complex with it.
Thioglycolic acid helps to oxidize iron (II) to iron (III).
36
Ammonia is added to make solution alkaline. The pale pink color is visible only
in the alkaline media. The color is not visible in acidic media as ferrous
thioglycolate complex decomposes in high acidic media.
37. Limit test for Chloride:
The test is used to limit the amount of Chloride as an impurity
in inorganic substances.
3
7
38. Limit test for CHLORIDE:
Principle:
Limit test of chloride is based on the reaction of soluble chloride with silver nitrate in
presence of dilute nitric acid to form silver chloride, which appears as solid particles
(Opalescence) in the solution.
Cl- +
Soluble
chloride
presentas
impurity
AgNO3 -------------------------- AgCl + NO3
-
silver chloride
38
impurity
The silver chloride produced in the presence of dilute Nitric acid makes the test solution
turbid, the extent of turbidity depending upon the amount of Chloride present in the
substance is compared with the standard opalescence produced by the addition of Silver
nitrate to a standard solution having a known amount of chloride and the same volume of
dilute nitric acid as used in the test solution.
40. Test sample Standard compound
Specific weight of compound
is dissolved in water
or solution is prepared as
directed in the pharmacopoeia
and transferred in Nessler
cylinder
Take 1 ml of 0.05845 % W/V
solution of sodium chloride in
Nessler cylinder
Add 1 ml of nitric acid Add 1 ml of nitric acidAdd 1 ml of nitric acid Add 1 ml of nitric acid
Dilute to 50 ml in Nessler cylinderDilute to 50 ml in Nessler cylinder
Add 1 ml of AgNO3 solution Add 1 ml of AgNO3 solution
Keep aside for 5 min Keep aside for 5 min
Observe the
Opalescence/Turbidity
Observe the Opalescence/Turbidity
40
41. Observation:
The opalescence produce in sample solution should not be greater than
standard solution. If opalescence produces in sample solution is less than the
standard solution, the sample will pass the limit test of chloride and visa
versa.
Reasons:
Nitric acid is added in the limit test of chloride to make
41
Nitric acid is added in the limit test of chloride to make
solution acidic and helps silver chloride precipitate to
make solution turbid at the end of process as Dilute HNO3
is insoluble inAgCl.
42. Pharmacopoeia does not prescribe any numerical value of limit test for chlorides,
sulphate and iron because limit test is based on the simple comparison of
opalescence or colour between the test and standard solution prescribed according to
pharmacopoeia.
In this type of limit test, the extent of turbidity or opalescence or colour produced in
influenced by the presence of other impurities present in the substance and also by
variation in time and method of performance of test.
Thus the pharmacopoeia does not prescribe any numerical value of the limit test.
Pharmacopoeia not prescribe any numerical value for limit test for chlorides,
sulphate and iron because limit test is based on simple comparison of opalescence orsulphate and iron because limit test is based on simple comparison of opalescence or
color between test and standard solution prescribed according to pharmacopoeia.
The variation in the permissible limits for various substances is obtained by taking
varying quantities of the substances under test. In this type of limit test, the extent of
opalescence or turbidity or color produced is influenced by the presence of other
impurities present in the substance and also by variation in time and method of
performance of tests and hence the pharmacopoeia do not prescribe any numerical
values for the limit test in these test.
42
43. The limit test involve simple comparisons of opalescence, turbidity, or colour with
standard.
These are semi-qualitative reactions in which extent of impurities present can be estimated
by comparing visible reaction response of the test and standard.
By this way, extent of reaction is readily determined by direct comparison of test solution
with standard. So pharmacopoeia prefers comparison methods.
43
44. Limit test for sulphate:
The Sulfate Limit Test is designed to determine the allowable limit of sulfate
contained in a
sample.
Principle:
Limit test of sulphate is based on the reaction of soluble sulphate with barium
chloride in presence of dilute hydrochloric acid to form barium sulphate
which appears as solid particles (turbidity) in the solution.
SO4 + BaCl2 --------------------------- BaSO4 +2Cl-2 -
Then comparison of turbidity is done with a standard turbidity obtained from a known
amount of Sulphate and same volume of dilute Hydrochloric acid have been added to both
solutions.
The barium chloride test solution in the IP has been replaced by Barium sulphate reagent
which is having barium chloride, sulphate free alcohol and a solution of potassium
sulphate. Potassium sulphate has been added to increase the sensitivity of the test.
44
45. Test sample Standard compound
Specific weight of compound is
dissolved in water or solution is
prepared as directed in the
pharmacopoeia and transferred in
Nessler cylinder
Take 1 ml of 0.1089 % W/V solution
of potassium sulphate in Nessler
cylinder
Add 2 ml of dilute hydrochloric acid Add 2 ml of dilute hydrochloric acid
Procedure:
45
Dilute to 45 ml in Nessler cylinder Dilute to 45 ml in Nessler cylinder
Add 5 ml of barium sulphate reagent Add 5 ml of barium sulphate reagent
Keep aside for 5 min Keep aside for 5 min
Observe the Turbidity Observe the Turbidity
46. Barium sulphate reagent contains barium chloride, sulphate free alcohol and small amount
of potassium sulphate.
Observation:
The turbidity produce in sample solution should not be greater than standard solution. If
turbidity produces in sample solution is less than the standard solution, the sample will pass
the limit test of sulphate and vice versa.
Reasons:
46
Hydrochloric acid helps to make solution acidic.
Potassium sulphate is used to increase the sensitivity of the test by giving ionic
concentration in the reagent.
Alcohol helps to prevent super saturation and so produces a more uniform opalescence.
47. Limit test for Arsenic:
Arsenic is a well known undesirable and harmful impurity which is present in medicinal
substances.
All pharmacopoeias prescribe a limit test for it.
Pharmacopoeial method is based on the Gutzeit test.
All the special reagents used in the limit test for Arsenic are marked and distinguished by
letter ‘As T’, which means that they all should be Arsenic free and should themselves
conform to the test forArsenic.
47
conform to the test forArsenic.
48. Principle:
Limit test of Arsenic is based on the reaction of arsenic gas with hydrogen ion to form
yellow stain on mercuric chloride paper in presence of reducing agents like
potassium iodide. It is also called as Gutzeit test and requires special apparatus.
Arsenic, present as arsenic acid (H3AsO4) in the sample is reduced to arsenious
acid (H3AsO3) by reducing agents like potassium iodide, stannous acid, zinc,
hydrochloric acid, etc. Arsenious acid is further reduced to arsine (gas) (AsH3)
by hydrogen and reacts with mercuric chloride paper to give a yellow stain.
Substance + dil HCl ------------------------- H3AsO4
(containsArsenic impurity) Arsenic acid
48
H3AsO4 +
Arsenic acid
H2SnO2 -------------------→ H3AsO3 +H2SnO3
Arsenious acid
H3AsO3 + 6[H] ---------------------→ AsH3 +3H2O
Arsenious acid nascent hydrogen Arsine gas
The depth of yellow stain on mercuric chloride paper will depend upon the
quantity of arsenic present in the sample.
49. When the sample is dissolved in acid, the Arsenic present in the sample
gets converted to Arsenic acid.
By action of reducing agents like Potassium iodide, stannous acid etc.,
Arsenic acid gets reduced to arsenious acid.
The nascent hydrogen formed during the reaction, further reduces
Arsenious acid to Arsine gas, which reacts with mercuric chloride paper,
giving a yellow stain.
49
51. Apparatus:
of It is having a wide mouthed glass bottle of 120 mL capacity having mouth of
about 2.5 cm in diameter. This bottle is fitted with a rubber bung through which
passes a glass
tube, 20 cm long.
External diameter=0.8 cm
Internal diameter=0.65 cm
The tube is constricted at its lower end extremity to about 1 mm diameter and there is
blown a hole, not less than 2 mm in diameter, in the side of the tube near the
constricted part.
The upper end of the glass tube is fitted with two rubber bungs(25 mm x 25 mm), each
51
having a hole bored centrally and exactly 6.5 mm in diameter.
One of the bungs has been fitted to the upper end of the tube, while the second bung
has to be fitted upon the first bung in such a way that the mercuric chloride paper
gets exactly sandwiched between the central perforation of the two.
The bungs are kept in close contact by using rubber band or spring clip in such a
manner that the gas evolved from the bottle must have to pass through the 0.65 mm
internal circle of mercuric chloride paper.
During the test, the evolved gases have been passing through the side hole, the lower
hole serving as an exit for water which condenses in the constricted part of the tube.
An important feature has been the standardization of the area of Mercuric chloride
paper which is exposed to the reaction of arsine gas.
52. Test sample Standard compound
The test solution is prepared by
dissolving specific amount in water
and stannated HCl (arsenic free) and
kept in a wide mouthed bottle.
A known quantity of dilute arsenic
solution in water and stannated HCl
(arsenic free) is kept in wide mouthed
bottle.
1 g of KI 1 g of KI
5 ml of stannous chloride acid solution 5 ml of stannous chloride acid solution
10 g of granulated zinc is added (all 10 g of zinc is added (all this reagents10 g of granulated zinc is added (all
this reagents must be arsenic free).
Keep the solution aside for 40 min
10 g of zinc is added (all this reagents
must be arsenic free).
Keep the solution aside for 40 min
52
Stain obtained on mercuric chloride paper is compared with standard solution.
Standard stain must be freshly prepared as it fades on keeping.
Inference: If the stain produced by the test is not deeper than the standard
stain, then sample complies with the limit test for Arsenic.
53. Reasons:
Stannous chloride is used for complete evolution of arsine.
Zinc, potassium iodide and stannous chloride is used as a reducing agent.
Hydrochloride acid is used to make the solution acidic
Lead acetate paper are used to trap any hydrogen sulphide which may be evolved
along with arsine.
53
54. Use of stannated Hydrochloric acid:
If pure zinc and HCl are used, the steady evolution of gas does not occur. This produces
improper stain (e.g slow evolution produces short but intense stain while rapid evolution of
gas produces long but diffused stain.)
So, to get steady evolution of gas, stannated hydrochloric acid is used.
Use of Lead Acetate solution:
H2S gas may be formed during the experiment as zinc contains sulphides as impurities. It
gives black stain to HgCl2 paper and so will interfere the test.
Hence, gases evolved are passed through cotton wool plug moistened with lead acetate,
where H S gas is trapped as PbS.where H2S gas is trapped as PbS.
Use of Potassium iodide:
KI is converted to HI which brings about reduction of unreacted pentavalent arsenic to
trivalent Arsenic. Thus, reproducible results can be obtained. If it is not used then some
pentavalent Arsenic may remain unreacted.
54
55. Limit test for heavy metals
The limit test for heavy metals is designed to determine the content of metallic impurities
that are coloured by hydrogen sulphide or sodium sulphide under the condition of the test
should not exceed the heavy metal limits given under the individual monograph.
The heavy metals (metallic impurities) may be iron, copper, lead, nickel, cobalt, bismuth,
antimony etc.. The limit for heavy metals is indicated in the individual monograph in
term of ppm of lead i.e. the parts of lead per million parts of the substance being
examined
In substances the proportion of any such impurity (Heavy metals) has been expressed as
the quantity of lead required to produce a color of equal depth as in a standard comparison
55
the quantity of lead required to produce a color of equal depth as in a standard comparison
solution having a definite quantity of lead nitrate.
The quantity is stated as the heavy metal limit and is expressed as parts of lead (by
weight) per million parts of the test substance.
The limit test for heavy metals has been based upon the reaction of the metal ion
with hydrogen sulphide, under the prescribed conditions of the test causing the
formation of metal sulphides.
These remain distributed in colloidal state, and give rise to a brownish coloration.
56. I.P limit for heavy metals in 20 ppm.
The test solution is compared with a standard prepared using a lead
solution (as the heavy metal).The metallic impurities in substance
are expressed as parts of lead per million parts of substance.
IP has adopted 3 methods for this:
Method I: The method is applicable for the samples which giveMethod I: The method is applicable for the samples which give
clear colourless solutions under specified conditions of test.
Method II: The method is applicablefor the samples
which DO NOT give clear colourless solutions under
specified conditions of test.
Method III: Used for substances which give
clear colourless solutions in sodium hydroxide
medium.
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57. Limit test for lead:
Lead is a most undesirable impurity in medical compounds
and comes through use of sulphuric acid, lead lined
apparatus and glass bottles use for storage of chemicals.
Principle:
57
Limit test of lead is based on the reaction of lead and diphenyl
thiocabazone (dithizone) in alkaline solution to form lead
dithizone complex which is red in color.
58. Dithizone in chloroform, is able to extract lead from alkaline
aqueous solutions as a lead dithizone complex (Red in colour)
The original dithizone is having a green colour in chloroform while
the lead- dithizone is having a violet color.So, resulting color at the
end of the process is read.
The intensity of the color of complex is dependant upon the
amount of lead in the solution.
The color of the lead-dithizone complex in chloroform has been
compared with a standard volume of lead solution, treated in thecompared with a standard volume of lead solution, treated in the
same manner.
In this method, the lead present as an impurity in the substances, gets
separated by extracting an alkaline solution with a dithizone
extraction solution.
The interference and influence of the other metal ions has been
eliminated by adjusting the optimum pH for the extraction by
employing Ammonium citrate/ potassium cyanide.
58
59. Method:
• Sample solution is transferred to a separating funnel.
• To it 6 ml of ammonium citrate, 2 ml potassium cyanide and 2
ml of hydroxalamine HCl
are added.
• 2 drops of phenol red
• Solution is made alkaline by adding ammonia solution.
• This is then extracted with 5 ml portions of dithizone solution
until it becomes green.until it becomes green.
• The combined dithizone extracts are shaken for 30 seconds
with 30 ml of nitric acid and chloroform layer is discarded.
• To the acid solution 5 ml of standard dithizone solution is
added and 4 ml ammonium cyanide and solution is shaken
for 30 sec.
• Similarly prepare standard.
59
60. Observation:
The intensity of the color of complex, is depends on the amount of
lead in the solution. The color produced in sample solution should
not be greater than standard solution. If color produces in sample
solution is less than the standard solution, the sample will pass the
limit test of lead and vice versa.
Reasons:
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citrate, potassium cyanide,
Reasons:
Ammonium
hydrochloride
hydroxylamine
is used to make pH optimum so interference and
of
influence of other impurities have been eliminated.
Phenol red is used as indicator to develop the color at the end of
process Lead present as an impurities in the substance, gets
separated by extracting an alkaline solution with a dithizone
extraction solution.
61. A known quantity of sample solution is
transferred in a separating funnel
A standard lead solution is prepared equivalent to
the amount of lead permitted in the sample under
examination
Add 6ml of ammonium citrate Add 6ml of ammonium citrate
Add 2 ml of potassium cyanide and 2 ml of
hydroxylamine hydrochloride
Add 2 ml of potassium cyanide and 2 ml of
hydroxylamine hydrochloride
Add 2 drops of phenol red Add 2 drops of phenol red
Make solution alkaline by adding ammonia solution. Make solution alkaline by adding ammonia solution.
Extract with 5 ml of dithizone until it becomes
green
Extract with 5 ml of dithizone until it becomes green
Combine dithizone extracts are shaken for 30 mins Combine dithizone extracts are shaken for 30 minsCombine dithizone extracts are shaken for 30 mins
with 30 ml of nitric acid and the chloroform layer is
discarded
Combine dithizone extracts are shaken for 30 mins
with 30 ml of nitric acid and the chloroform layer is
discarded
To the acid solution add 5 ml of standard dithizone
solution
To the acid solution add 5 ml of standard dithizone
solution
Add 4 ml of ammonium cyanide Add 4 ml of ammonium cyanide
Shake for 30 mins Shake for 30 mins
Observe the color Observe the color
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62. Aq. Ammonia is added in limit test of lead:
Pb+ S-------------PbS
In limit test of lead, PbS is produced by addition of standard H2S ,
to the solution containing lead.
pH 3-4 is necessary for the precipitation of PbS. So aq.
Ammonia / acetic acid is added to maintain that pH.
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63. Modified limit test for Chlorides
Depending upon the nature of the substance,
some modifications have to be adopted for the
preparation of the solution.
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64. Modified limit test for Chlorides
(a)Alkaline substances have to be dissolved in acid so that effervescence ceases and
much of the free acid is left in the solution as is prescribed in the test.
(b)Insoluble substances are generally extracted with water and then filtered, and
the filtrate is used for the test, because the presence of insoluble substance
modifies the opalescence and colour.
(c)Salts of organic acids like sodium benzoate, sodium salicylate, etc. liberate free
water insoluble organic acid during acidification which is filtered off and the
filtrate is employed for the test.
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filtrate is employed for the test.
(d) Coloured substances like crystal violet, malachite green, etc. are carbonised
and the
ash so produced is extracted in water.
(e)Deeply coloured substances have to be decolourised before test e.g., potassium
permanganate is reduced by boiling with alcohol and the filtrate is used.
(f)Reducing substances like hypophosphorus acid, which react with silver nitrate in
the limit test for chlorides should be oxidized with nitric acid or some other
oxidizing agents before carrying out the test.
65. Modified limit test for Chlorides
Aim To perform the limit test for chloride in potassium permanganate sample (according to
IP’96)
Requirement:
Nessler’s cylinder, measuring cylinder, pipette, spatula, distilled water, dilute nitric acid, 0.1
M silver nitrate solution, potassium permanganate sample
Principle:
The limit test for chloride based on the reaction between soluble chloride impurities present in the
substance and silver nitrate solution to give white precipitates of silver chloride. These white
65
of
substance and silver nitrate solution to give white precipitates of silver chloride. These white
precipitates are insoluble in dilute nitric acid and hence give turbidity or opalescence to the test
solution. The extent of the turbidity produced depends upon the amount of the chloride present in
the substance which is compared with a standard opalescence produce by addition of silver
nitrate to a standard solution having known amount of chloride and the same volume of the dilute
nitric acid as the use in the test solution. If the turbidity developed in the sample is less than the
standard turbidity, the sample passes the limit test for chloride and vice-versa. As potassium
permanganate gives purple color aqueous solution that interferes in the comparison of
opalescence or turbidity, therefore the aqueous solution must first be decolorized.
Potassium permanganate is oxidizing agent while ethanol is reducing agent.
66. When potassium permanganate solution is treated with ethanol
in presence of heat the redox reaction will take place, i.e.
potassium permanganate gets reduced to manganese dioxide
(precipitates). The filtrate of the reaction is colorless that is
subjected to proceed for limit test for chloride.
66
67. Chemical Reaction:
4 2 5 2 3 22 KMnO4 + 3 C2H5OH---------- 2 MnO2 + 2 KOH + 2 CH3CHO + 2 H2O
Sr.
No.
STANDARD SOLUTION SR.
NO
TEST SOLUTION
1 Take 10 ml chloride standard
solution (25 ppm
chloride) and add 5 ml water in a
Nessler’s cylinder.
1 Transfer the prepared test solution
in Nessler’s
cylinder
2 Add 10 ml of dilute nitric acid and
dilute to 50 ml
2 Add 10 ml of dilute nitric acid and
dilute to 50
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dilute to 50 ml
with distilled water
dilute to 50
ml with distilled water
3 Add 1ml of 0.1 M silver nitrate
solution and stir
immediately with glass rod and
allow standing for 5 minutes
protected from light.
3 Add 1ml of 0.1 M silver nitrate
solution and
stir immediately with glass rod and
allow standing for 5 minutes
protected from light.
Compare the turbidity or opalescence produced in test solution with respect to
standard solution and report the result and conclusion.
68. Observation and conclusion:
Observation and conclusion will be of two types:
If the intensity of turbidity or opalescence appears to be more in
test solution than the standard solution then conclusion is
impurities of
chloride in given sample is over the limit as per IP’96. Hence,chloride in given sample is over the limit as per IP’96. Hence,
sample do not passes the limit test for chlorides.
If the intensity turbidity or opalescence appears to be less or equal
in test solution than the standard solution then conclusion is
impurities of chloride in given sample is under the limit as per
IP’96. Hence, sample passes the limit test for chloride
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69. To perform the limit test for sulphate in Potassium
permanganate sample (According to IP’96)
Principle:
It is a comparison method. It involves the comparison of opalescence or turbidity of test
sample verses standard sample which contain the definite amount of sulphate impurities.
The limit test of sulphate is performed on the basis of reaction between the barium
chloride reagent (containing barium chloride, sulphate free alcohol and solution of
potassium sulphate (K2SO4) and soluble sulphate in the sample with formation of
barium sulphate (BaSO4) white precipitates.
Sulphate free alcoholic potassium sulphate is added to increase the sensitivity of the test.
Very small amount of barium sulphate present in the reagents acts as a seeding agents for
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dioxide (precipitates)
Very small amount of barium sulphate present in the reagents acts as a seeding agents for
precipitation of barium sulphate, if sulphate is present in the sample under the test.
Ethanol is added to prevent the super saturation i.e. the crystallization of sulphate with any
other ion.
As potassium permanganate gives purple colored aqueous solution that interferes in the
comparison of opalescence or turbidity, therefore it requires to be decolorized. Potassium
permanganate is oxidizing agent while ethanol is reducing agent. When potassium
permanganate solution is treated with ethanol in presence of heat the redox reaction
takes place, i.e. potassium permanganate gets reduced to manganese dioxide (precipitates)
and ethanol gets oxidized to form ethanal. The filtrate of the reaction is colorless that is
subjected to proceed for limit test for sulphate.
70. Sr.
No.
STANDARD SOLUTION SR.
NO
TEST SOLUTION
1 Take 1 ml 25% w/v barium
chloride in Nessler’s
cylinder and add 1.5 ml of
ethanolic sulphate standard
solution (10 ppm SO -2). Mix and
1 Take 1 ml 25% w/v barium
chloride in Nessler’s
cylinder and add 1.5 ml of
ethanolic sulphate standard
solution (10 ppm SO -2). Mix and
Reaction:
4 2 5 2 3 22 KMnO4 + 3 C2H5OH -------------------- 2 MnO2 + 2 KOH + 2 CH3CHO + 2 H2O
solution (10 ppm SO4
-2). Mix and
allow to stand for 1 minutes
solution (10 ppm SO4
-2). Mix and
allow to stand for 1 minutes
2 Add 15 ml of standard sulphate
solution (10 ppm
SO4
-2) and 0.15 ml of 5M acetic
acid.
2 Transfer prepared test solution
and add 0.15 ml of
5 M acetic acid.
3 Add sufficient distilled water to
produced 50 ml.
Stirred it immediately and allow
standing for 5 minutes.
3 Add sufficient distilled water to
produced 50 ml.
Stirred it immediately and allow
standing for 5 minutes.
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71. • Compare the turbidity or opalescence in the test
solution by viewing transversely both solutions
against black background.
71
Prepared by:Prepared by:
Asst. Prof. Mr. Raju Yadav
M.S. Pharm NIPER
Department of Pharmaceutical Chemistry
Note: If you have any query feel free to contact me:
Mob: +919918575512
Email ID: rajuyadavkip123@gmail.com