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
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.
Pharmaceutical Inorganic Chemistry -B Pharmacy First Year -First semester -PI...manjusha kareppa
This document provides an overview of gastrointestinal agents used to treat various gastrointestinal disorders. It discusses acidifiers that increase acid in the stomach and are used to treat achlorhydria. It also covers antacids that neutralize excess stomach acid and are used for hyperacidity/hyperchlorhydria. Finally, it discusses cathartics/laxatives that relieve constipation through increasing bowel movements. Specific agents covered include ammonium chloride, dilute hydrochloric acid, sodium bicarbonate, aluminum hydroxide gel, and magnesium hydroxide mixture.
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
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.
Pharmaceutical Inorganic Chemistry -B Pharmacy First Year -First semester -PI...manjusha kareppa
This document provides an overview of gastrointestinal agents used to treat various gastrointestinal disorders. It discusses acidifiers that increase acid in the stomach and are used to treat achlorhydria. It also covers antacids that neutralize excess stomach acid and are used for hyperacidity/hyperchlorhydria. Finally, it discusses cathartics/laxatives that relieve constipation through increasing bowel movements. Specific agents covered include ammonium chloride, dilute hydrochloric acid, sodium bicarbonate, aluminum hydroxide gel, and magnesium hydroxide mixture.
The document describes limit tests for various inorganic impurities that may be present in compounds. It discusses the principles, procedures, and observations for limit tests of chlorides, sulphates, iron, lead, arsenic, and heavy metals. The tests involve preparing test and standard solutions, and comparing a property such as turbidity, color formation, or stain intensity between the two. If the property from the test solution is less than the standard, then the sample passes the limit test for that impurity. The document provides detailed procedures for each limit test.
The document discusses electrolyte balance and acid-base balance in the body. It provides details on various electrolytes like sodium, potassium, calcium salts and their role in maintaining balance. It also discusses the buffer systems and mechanisms involved in regulating pH of blood and treatment of acid-base imbalances. Specifically, it summarizes commonly used pharmaceutical compounds for correcting acid-base imbalances like sodium bicarbonate, sodium acetate, potassium acetate and their properties, methods of preparation, uses and official preparations.
pharmacopoeia and monograph, pharmaceutical inorganic chemistrynehla313
The document discusses various pharmacopoeias including the Indian Pharmacopoeia, British Pharmacopoeia, and United States Pharmacopoeia. It provides details on the history, editions, contents and features of these pharmacopoeias. The key points are:
- Pharmacopoeias are official books that provide drug standards and monographs. They are usually issued by government authorities.
- The first edition of the Indian Pharmacopoeia was published in 1955. It has since been revised periodically with additions of new monographs and analytical methods.
- The British Pharmacopoeia was first published in 1864 and has been published annually since 1953. It contains over 3,000 monographs for substances
Internal protectives and adsorbents are inorganic pharmaceuticals used to treat mild diarrhea by coating the stomach and intestinal mucosa. Bismuth subcarbonate is a commonly used protective that is a white or pale yellow powder stored in light-resistant containers. Magnesium sulfate is an osmotic laxative used to treat constipation that is colorless needles soluble in water. Sodium potassium tartrate is also a saline cathartic that is white crystals or prisms with a cooling saline taste, used as a laxative or in effervescent powders.
This document provides an overview of semi-solid dosage forms. It defines semi-solids as products that tend to alleviate or treat pathological conditions when applied to the skin or mucous membranes. Ideal properties include a smooth texture, elegant appearance, and non-irritating qualities. Common types are ointments, creams, pastes, gels, and suppositories. Formulation involves selecting appropriate bases, preservatives, and other excipients. Methods of preparation include size reduction, levigation, mixing, homogenization, and filling. Evaluation tests physical properties, drug release, and stability.
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.
Unit 1 PHARMACEUTICAL INORGANIC CHEMISTRYSayali Powar
The document discusses various limit tests performed as per the Indian Pharmacopoeia to determine the presence of impurities below specified limits. It describes the principles, procedures and observations for limit tests of chloride, sulphate, iron, arsenic, heavy metals and lead. Limit tests involve comparing the color or turbidity developed in a test sample to a standard under defined reaction conditions. They provide a semi-quantitative analysis to check if impurity levels pass specified limits in the pharmacopoeia.
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.
This document discusses electrolyte therapy, including normal electrolyte requirements, solutions for initial and subsequent electrolyte replacement, and the ingredients and amounts in oral rehydration salts. It lists the normal requirements in meq/L or meq/liter for electrolytes like sodium, potassium, chloride, bicarbonate, magnesium, calcium, and phosphorous. It also provides the formulation for oral rehydration salts, including the active ingredients dextrose monohydrate, potassium chloride, sodium citrate, and the amounts needed to make up 1000ml of solution.
The document summarizes the gastrointestinal tract (GIT) and various drugs used to treat GIT disorders. It describes the main organs of the GIT including the mouth, esophagus, stomach, small intestine, and large intestine. It then discusses drugs used to treat acidity/hyperacidity conditions like antacids and acidifiers. Other drugs discussed include cathartics to treat constipation and protectives/adsorbents for diarrhea. The mechanisms of several antimicrobial agents are also outlined.
Impurities in Pharmaceutical substancesUrmilaBudhe
This document provides an overview of inorganic chemistry and pharmaceutical inorganic chemistry. It discusses the importance of inorganic pharmaceuticals and their uses. It also covers topics like the history and development of pharmacopoeias including the Indian Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopoeia. Finally, it discusses impurities in pharmaceutical substances, sources of impurities, effects of impurities, and tests for purity like limit tests that are prescribed in pharmacopoeias.
The document provides an introduction to pharmacopoeias. It defines a pharmacopoeia as an official book published by a government that contains lists of drugs and formulas for medical preparations along with tests, descriptions, and standards. It discusses the objectives and importance of pharmacopoeias in providing information, quality control, and standards. The history of major pharmacopoeias is summarized, including the first editions of the Indian, British, and US pharmacopoeias. Key features of revisions and editions of the Pharmacopoeia of India are highlighted.
This document discusses electrolyte replacement therapy and lists three common electrolyte compounds used: sodium chloride, potassium chloride, and calcium gluconate. Sodium chloride and potassium chloride are described in detail, including their molecular formulas, properties, preparation methods, assays, and uses. Calcium gluconate is also described briefly, noting its use as an electrolyte replenisher and to treat conditions caused by low calcium levels such as osteoporosis and rickets. The main purpose of electrolyte replacement therapy is to restore electrolyte and fluid balance in the body.
UNIT II PHARMACEUTICAL INORGANIC CHEMISTRYSayali Powar
The document discusses major extra and intracellular electrolytes. It begins with an introduction to electrolytes, noting that they dissociate into cations and anions when dissolved in body fluids. It then describes the two main body fluid compartments: intracellular fluid contained within cells, and extracellular fluid outside of cells, consisting of plasma and interstitial fluid between cells. Finally, it discusses the importance of electrolyte balance for proper cell and organ function.
The document provides an overview of pharmacopoeias and details the history and development of the Pharmacopoeia of India. It discusses how the Indian Pharmacopoeial List was first published in 1946, followed by the Indian Pharmaceutical Codex in 1953. The first edition of the Pharmacopoeia of India was then published in 1955. Subsequent editions in 1985, 1996, 2010, and 2014 introduced new analytical techniques, testing methods, and drug standards. The document outlines some key features and changes between editions, such as introducing dissolution testing, additional identification tests, and recognizing new analytical methods like HPLC and infrared spectroscopy.
Introduction to liniment and turpentine linimentkopalsharma85
The document provides instructions for preparing a 30 mL liniment of turpentine by first making an emulsion of soft soap, turpentine oil, and camphor and then adding water to reach the final volume, to be used externally for conditions like arthritis, muscle pain, and nerve pain by counterirritant and irritant mechanisms of the ingredients. Key ingredients in the liniment include soft soap as an emulsifying agent, turpentine oil and camphor as rubefacients and counterirritants, and the liniment is applied topically with gentle rubbing to provide relief from deep-seated pain.
This document describes the limit test for iron according to the Indian Pharmacopoeia. The test involves comparing the color produced by reacting a sample with thioglycolic acid in an ammonical citrate buffer to the color produced by a standard iron solution under the same conditions. If the color produced by the sample is less than the standard, it passes the limit test for iron. If the color is greater than the standard, it fails the limit test. The test is sensitive and uses citric acid to eliminate interference from other metal cations.
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
Impurity is the undesirable foreign material which may be toxic or non toxic present in the pharmaceutical substance.
Impurity is the substance or the matter which does not form a part of the medicinal or pharmaceutical substance or drugs.
Sources of impurities include
1. Raw materials used in the manufacturer.
2. Process used in the manufacturer.
3. Material of the plant.
4. Inadequate storage.
5. Accidental substitutions/deliberate adulteration with spurious/ useless substance.
6. Manufacturing hazards.
This ppt also explain Effects of impurities in pharmacopoeial substance.
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 describes limit tests for various inorganic impurities that may be present in compounds. It discusses the principles, procedures, and observations for limit tests of chlorides, sulphates, iron, lead, arsenic, and heavy metals. The tests involve preparing test and standard solutions, and comparing a property such as turbidity, color formation, or stain intensity between the two. If the property from the test solution is less than the standard, then the sample passes the limit test for that impurity. The document provides detailed procedures for each limit test.
The document discusses electrolyte balance and acid-base balance in the body. It provides details on various electrolytes like sodium, potassium, calcium salts and their role in maintaining balance. It also discusses the buffer systems and mechanisms involved in regulating pH of blood and treatment of acid-base imbalances. Specifically, it summarizes commonly used pharmaceutical compounds for correcting acid-base imbalances like sodium bicarbonate, sodium acetate, potassium acetate and their properties, methods of preparation, uses and official preparations.
pharmacopoeia and monograph, pharmaceutical inorganic chemistrynehla313
The document discusses various pharmacopoeias including the Indian Pharmacopoeia, British Pharmacopoeia, and United States Pharmacopoeia. It provides details on the history, editions, contents and features of these pharmacopoeias. The key points are:
- Pharmacopoeias are official books that provide drug standards and monographs. They are usually issued by government authorities.
- The first edition of the Indian Pharmacopoeia was published in 1955. It has since been revised periodically with additions of new monographs and analytical methods.
- The British Pharmacopoeia was first published in 1864 and has been published annually since 1953. It contains over 3,000 monographs for substances
Internal protectives and adsorbents are inorganic pharmaceuticals used to treat mild diarrhea by coating the stomach and intestinal mucosa. Bismuth subcarbonate is a commonly used protective that is a white or pale yellow powder stored in light-resistant containers. Magnesium sulfate is an osmotic laxative used to treat constipation that is colorless needles soluble in water. Sodium potassium tartrate is also a saline cathartic that is white crystals or prisms with a cooling saline taste, used as a laxative or in effervescent powders.
This document provides an overview of semi-solid dosage forms. It defines semi-solids as products that tend to alleviate or treat pathological conditions when applied to the skin or mucous membranes. Ideal properties include a smooth texture, elegant appearance, and non-irritating qualities. Common types are ointments, creams, pastes, gels, and suppositories. Formulation involves selecting appropriate bases, preservatives, and other excipients. Methods of preparation include size reduction, levigation, mixing, homogenization, and filling. Evaluation tests physical properties, drug release, and stability.
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.
Unit 1 PHARMACEUTICAL INORGANIC CHEMISTRYSayali Powar
The document discusses various limit tests performed as per the Indian Pharmacopoeia to determine the presence of impurities below specified limits. It describes the principles, procedures and observations for limit tests of chloride, sulphate, iron, arsenic, heavy metals and lead. Limit tests involve comparing the color or turbidity developed in a test sample to a standard under defined reaction conditions. They provide a semi-quantitative analysis to check if impurity levels pass specified limits in the pharmacopoeia.
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.
This document discusses electrolyte therapy, including normal electrolyte requirements, solutions for initial and subsequent electrolyte replacement, and the ingredients and amounts in oral rehydration salts. It lists the normal requirements in meq/L or meq/liter for electrolytes like sodium, potassium, chloride, bicarbonate, magnesium, calcium, and phosphorous. It also provides the formulation for oral rehydration salts, including the active ingredients dextrose monohydrate, potassium chloride, sodium citrate, and the amounts needed to make up 1000ml of solution.
The document summarizes the gastrointestinal tract (GIT) and various drugs used to treat GIT disorders. It describes the main organs of the GIT including the mouth, esophagus, stomach, small intestine, and large intestine. It then discusses drugs used to treat acidity/hyperacidity conditions like antacids and acidifiers. Other drugs discussed include cathartics to treat constipation and protectives/adsorbents for diarrhea. The mechanisms of several antimicrobial agents are also outlined.
Impurities in Pharmaceutical substancesUrmilaBudhe
This document provides an overview of inorganic chemistry and pharmaceutical inorganic chemistry. It discusses the importance of inorganic pharmaceuticals and their uses. It also covers topics like the history and development of pharmacopoeias including the Indian Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopoeia. Finally, it discusses impurities in pharmaceutical substances, sources of impurities, effects of impurities, and tests for purity like limit tests that are prescribed in pharmacopoeias.
The document provides an introduction to pharmacopoeias. It defines a pharmacopoeia as an official book published by a government that contains lists of drugs and formulas for medical preparations along with tests, descriptions, and standards. It discusses the objectives and importance of pharmacopoeias in providing information, quality control, and standards. The history of major pharmacopoeias is summarized, including the first editions of the Indian, British, and US pharmacopoeias. Key features of revisions and editions of the Pharmacopoeia of India are highlighted.
This document discusses electrolyte replacement therapy and lists three common electrolyte compounds used: sodium chloride, potassium chloride, and calcium gluconate. Sodium chloride and potassium chloride are described in detail, including their molecular formulas, properties, preparation methods, assays, and uses. Calcium gluconate is also described briefly, noting its use as an electrolyte replenisher and to treat conditions caused by low calcium levels such as osteoporosis and rickets. The main purpose of electrolyte replacement therapy is to restore electrolyte and fluid balance in the body.
UNIT II PHARMACEUTICAL INORGANIC CHEMISTRYSayali Powar
The document discusses major extra and intracellular electrolytes. It begins with an introduction to electrolytes, noting that they dissociate into cations and anions when dissolved in body fluids. It then describes the two main body fluid compartments: intracellular fluid contained within cells, and extracellular fluid outside of cells, consisting of plasma and interstitial fluid between cells. Finally, it discusses the importance of electrolyte balance for proper cell and organ function.
The document provides an overview of pharmacopoeias and details the history and development of the Pharmacopoeia of India. It discusses how the Indian Pharmacopoeial List was first published in 1946, followed by the Indian Pharmaceutical Codex in 1953. The first edition of the Pharmacopoeia of India was then published in 1955. Subsequent editions in 1985, 1996, 2010, and 2014 introduced new analytical techniques, testing methods, and drug standards. The document outlines some key features and changes between editions, such as introducing dissolution testing, additional identification tests, and recognizing new analytical methods like HPLC and infrared spectroscopy.
Introduction to liniment and turpentine linimentkopalsharma85
The document provides instructions for preparing a 30 mL liniment of turpentine by first making an emulsion of soft soap, turpentine oil, and camphor and then adding water to reach the final volume, to be used externally for conditions like arthritis, muscle pain, and nerve pain by counterirritant and irritant mechanisms of the ingredients. Key ingredients in the liniment include soft soap as an emulsifying agent, turpentine oil and camphor as rubefacients and counterirritants, and the liniment is applied topically with gentle rubbing to provide relief from deep-seated pain.
This document describes the limit test for iron according to the Indian Pharmacopoeia. The test involves comparing the color produced by reacting a sample with thioglycolic acid in an ammonical citrate buffer to the color produced by a standard iron solution under the same conditions. If the color produced by the sample is less than the standard, it passes the limit test for iron. If the color is greater than the standard, it fails the limit test. The test is sensitive and uses citric acid to eliminate interference from other metal cations.
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
Impurity is the undesirable foreign material which may be toxic or non toxic present in the pharmaceutical substance.
Impurity is the substance or the matter which does not form a part of the medicinal or pharmaceutical substance or drugs.
Sources of impurities include
1. Raw materials used in the manufacturer.
2. Process used in the manufacturer.
3. Material of the plant.
4. Inadequate storage.
5. Accidental substitutions/deliberate adulteration with spurious/ useless substance.
6. Manufacturing hazards.
This ppt also explain Effects of impurities in pharmacopoeial substance.
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
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
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.
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.
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.
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.
Pharmaceutical impurity and limit test_by_Raju_Yadav_M.S._Pharm_NIPER_2020RajYadav238
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.
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.
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.
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.
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.
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.
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.
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.
This document discusses the sources and types of impurities in pharmaceutical chemistry. It begins by defining impurities as any component of a drug substance that is not the defined chemical entity. Impurities are then classified into organic, inorganic, and residual solvents. Organic impurities can arise from starting materials, byproducts, intermediates, or degradation. Inorganic impurities involve reagents, metals, or salts. Residual solvents are volatile chemicals used in manufacturing. Common sources of impurities are listed as raw materials, reagents, solvents, intermediates, and atmospheric contamination during manufacturing. The document also outlines effects of impurities and official testing methods.
This document discusses sources of impurities in pharmaceutical manufacturing. It identifies potential impurities from reagents, equipment, and process errors. Reagents and solvents can react with equipment materials like glass, metals, and alloys. Process errors like improper mixing, filtration, or concentration can also introduce impurities. Particulate contamination may occur from extruded metal particles in packaging. Special care is needed to avoid errors in potent or low dosage drugs. Microbial contamination is a risk, especially for products using natural raw materials, and sterility testing is important. Overall, strict control of materials, equipment, processes, and testing is needed to minimize impurities in pharmaceutical products.
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.
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2. The word impurity deals with the state/quality of being impure.
Impurities are the substances which makes something less pure.
It is also defined as any unwanted substance existing with active/main
drug.
The impurities observed in the drug substances may arises with raw
material or during various manufacturing processes or may be due to side
reactions also.
If a compound contains/have the foreign materials/substances,then such
compound is said to be impure or impurities present in that compound.
Following are the some effects of impurities,
1.Impurities may bring about incompatibility with other substances.
2.Impurities may lower the shelf life of the substance.
3.Impurities may cause difficulties during formulation and use of the
substances.
4.Sometimes impurities changes the physical and chemical properties of
the substances.
5. Imurities may creats the technical problems while preparing the
drug/medicine.
6.Impurities overall affect the quality of drug and profit also.
3. Following are the some sources of impurities which arises in any
pharmaceutical preparations/medicines.
1.The raw material used in the manufacturing of drugs/medicines-
The pharmaceutical preparations/ drugs are prepared from natural
sources/from chemicals.
If such natural sources/chemicals contains impurities,it passes and
contaminates the final product.
So it is very essential to verify and check the source of material used
and quality during the manufacturing of pharmaceutical preparations/
drugs.
Eg.sodium chloride- as it is prepared from rock salts (a natural source)
which consist of small amounts of calcium sulphate and magnesium
chloride,so sodium chloride also contains traces of calcium and
magnecium compound as an impurity.
4. 2.The manufacturing of process/method -
The manufacturing process/method also introduce the new
impurities which leads to the contamination of final product.
Reagent – The impurities due to the use of reagents,solvants,reaction
vessles and sometimes due to intermediates also.
Eg.the anions like Cl- and SO₄ are common impurities arise due to the
use of hydrochloric acid and sulphuric acid.
Solvants- The solvants used during manufacturing and purification
process may also leads to contamination of final product.
Eg.water – the main solvent used in various processes contains
number impurities like ca2+,mg2+,Na, Cl- etc.
Intermediates – It may contaminates the final product.
Reaction vessels – During manufacturing process some
chemicals undergo metallic reactions with vessles such as
copper,iron,aluminium and even stainless steel.
So when the inorganic compounds are prepared in these vessels,small
amount of impurities of the metals are likely to be present and that
contaminates the final product.
5. 3.The chemical process used during manufacturing –
During the pharmaceutical sunstances/drugs
various chemical reactions are carried out like
oxidation,reduction,nitration,sulphonation,halogenation etc.
So during all these chemical process/reaction various chemicals are
used.
Eg.water – which is mainly used during all the above chemical
reactions and it contaminates the final product as it contains ca
2+,mg2+,Na, Cl- etc ions impurities.
4.Atmospheric contamination during manufacturing process –
The atmosphere may consist of different gases and dust/durt
particles like sulphur,silica,plastic fragments,aluminium oxide.
These dust particles and gases may enter during the manufacturing
process and leads to contamination of final product.
Eg.sodium hydroxide,it absorb the atmospheric carbondioxide
when it exposed to the atmosphere and leads to contamination of
final product.
6. 5.Manufacturing Hazards –
There are many possibilities of contamination by impurities even in
well run manufacturing house.
Sometimes the unwanted Particulate matter can arise by accidental
introduction of dust/durt/glass,metallic,plastic fragments from
various containers/machines like sieve,tabletting,granulatting and
filling machines.
Eg.metal particles which found in eye ointment due to the packing in
metal tubes.
Sometimes cross-contamination of the product may occur by the
air-born dust arising due to handling of bulk-large powders,granules
and tablets.
Cross –contamination arises when two or more products are
manufactured in same premices
7. 6.Storage conditions –
Depending upon the nature of
chemicals/drugs their storage conditions may vary.
It depends on nature of material,its quality,size etc.
There are various types of containers are available in market which
may be made up of plastic,glass,stainless steel,alumunium,iron etc.
Sometimes the container may react with the stored chemicals/drugs
in it and leads to various physic-chemical changes which are
considered as impurities and responsible for complete loss of final
product.
Eg.when ferrous sulphate is not stored in well closed container,it
slowly gets changed into insoluble ferric oxide due to presence of
atmospheric air and moisture.
If the surgical solutions of chlorinated soda is not stored in amber
coloured bottles in cool place ,it leads to deterioration as it reacts
with light and heat.