This document provides procedures for detecting and removing peroxide contamination from chemicals using activated alumina balls. It describes three methods for detecting peroxides, including using test strips that indicate concentrations from 0-25 ppm. Peroxide concentrations above 30 ppm pose explosion risks, so the document outlines removing low peroxide levels by filtering through activated alumina columns and never opening containers with visible crystals.
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.
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
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.
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
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.
Sources of impurities, raw materials as a source of impurity, manufacturing methods as a source of impurity, reagents, solvents and reaction vessels as a source of impurity, manufacturing hazards as a source of impurity, physical and chemical stability of pharmaceuticals during storage, the reaction of pharmaceuticals with containers or storage vessels, thermal decomposition of pharmaceuticals, the use of water in the pharmaceutical industry, atmospheric contamination as a source of impurity, intermediate compounds as a source of impurity, cross-contamination of pharmaceutical powders, contamination of drugs by microbes, contamination of pharmaceuticals by particulate matter, errors in the manufacturing process as a source of impurity, storage of pharmaceuticals in amber-colored bottles, storage of drugs in a cool temperature, rubber closures as a source of impurity, natural sources of drugs, animal sources of drugs, plant sources of drugs, microorganism as a source of drugs, minerals as a source of drugs, effect of arsenic in human body, effect of excess of chlorine, iron and sulphate in human body, types of impurity.
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Plasitnation as a sub-unit of museum techniques has been helpful as gross specimen for postgraduate, undergraduate and research studies. Why is so plastination important in the 21th Century?
Containers are in intimate contact with the product. No container presently available is totally non reactive, particularly with aqueous solutions . Both the chemical and physical characteristics are given primary consideration in the selection of a protective container . Glass containers traditionally have been used for sterile products , many of which are closed with rubber stoppers. Interest in plastic containers for parenterals is increasing and such containers are being used for commercial ophthalmic preparations and IV solutions.
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Are you properly managing your peroxide forming chemicals? If not properly managed or identified, these chemicals can form peroxides that can result in dangerous or even fatal explosions.This guide will teach you what peroxide formers are and how they form, the dos and donts of peroxide former protocol and maintenance, peroxide former planning for the future and more.
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.
Sources of impurities, raw materials as a source of impurity, manufacturing methods as a source of impurity, reagents, solvents and reaction vessels as a source of impurity, manufacturing hazards as a source of impurity, physical and chemical stability of pharmaceuticals during storage, the reaction of pharmaceuticals with containers or storage vessels, thermal decomposition of pharmaceuticals, the use of water in the pharmaceutical industry, atmospheric contamination as a source of impurity, intermediate compounds as a source of impurity, cross-contamination of pharmaceutical powders, contamination of drugs by microbes, contamination of pharmaceuticals by particulate matter, errors in the manufacturing process as a source of impurity, storage of pharmaceuticals in amber-colored bottles, storage of drugs in a cool temperature, rubber closures as a source of impurity, natural sources of drugs, animal sources of drugs, plant sources of drugs, microorganism as a source of drugs, minerals as a source of drugs, effect of arsenic in human body, effect of excess of chlorine, iron and sulphate in human body, types of impurity.
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Plasitnation as a sub-unit of museum techniques has been helpful as gross specimen for postgraduate, undergraduate and research studies. Why is so plastination important in the 21th Century?
Containers are in intimate contact with the product. No container presently available is totally non reactive, particularly with aqueous solutions . Both the chemical and physical characteristics are given primary consideration in the selection of a protective container . Glass containers traditionally have been used for sterile products , many of which are closed with rubber stoppers. Interest in plastic containers for parenterals is increasing and such containers are being used for commercial ophthalmic preparations and IV solutions.
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The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
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Are you properly managing your peroxide forming chemicals? If not properly managed or identified, these chemicals can form peroxides that can result in dangerous or even fatal explosions.This guide will teach you what peroxide formers are and how they form, the dos and donts of peroxide former protocol and maintenance, peroxide former planning for the future and more.
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.
Safe Use and Storage of Chemicals and ReagentsTapeshwar Yadav
Even in the smallest laboratory, dangerous chemicals are used directly or incorporated into stains and reagents.
Hence the correct handling and storage of hazardous chemicals is essential to prevent injury and damage.
In addition to this, to reduce accidents caused by chemicals, labeling is very important.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with "Quality control of packaging materials."
Thank you for reading.
we hope it was helpful to you.
UIPS,PU team
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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.
Desiccant canisters are commonly used as moisture absorbers in various applications to protect products and materials from humidity and moisture damage.
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In the Process of generating Nitrogen, Carbon Molecular Sieve (CMS) plays a very vital role. With the help of CMS only Nitrogen is produced. CMS takes up the oxygen, carbon dioxide and other impurities and release the pure nitrogen.
PSA is one of the unique processes in which gases are separated with the help of pressure swing technology is called PSA. In this process when the bed is in desorption mode with the help of release pressure it is been regenerated and then to swing to adsorption mode.
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Desiccants, as we all know, are specially designed to remove all traces of moisture from packed spaces. They are very important for the storage and transportation industry as here goods are packed and kept in closed spaces for days together. Container Desiccant protects shipping cargo not only from condensation, but from mold, mildew, rust and corrosion when the goods are being transported.
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Removal of peroxide from thf mfg of thf using activated alumina balls
1. PROCEDURES FOR DETECTING AND REMOVING
PEROXIDE CONTAMINATION using activated alumina balls
Detection of Peroxides
Before distilling or purifying any known or suspected peroxide-former, check it carefully for the
presence of peroxides. Either of the following tests will detect most (but not all) peroxy
compounds including all hydroperoxides:
1. Add 1-3 ml of the liquid to be tested to an equal volume of acetic acid, add a few
drops of 5% aqueous KI solution, and shake. The appearance of a yellow to brown
color indicates the presence of peroxides.
2. Add 0.5 ml of the liquid to be tested to a mixture of 1 ml of 10% aqueous KI
solution and 0.5 ml of dilute HCl to which has been added a few drops of starch
solution just prior to the test. The appearance of a blue or blue-black color within
a minute indicates the presence of peroxides.
3. The easiest method of detecting peroxides in common solvents is to use
peroxide test strips that are semi-quantitative and give readings in the range from
0 - 25 ppm. These strips are available from Physical Science Storehouse.
Test Results:
>03-30 parts per million (ppm) - Expired compounds testing within this range offer little or no
threat of violent reaction on the given test date. For compounds testing in this range, the
investigator should consider the addition of fresh inhibitor to retard the auto-oxidation process and
the container should be tightly sealed to prevent air and light exposure.
>30 and <80 ppm - Expired or mismanaged compounds originally inhibited by the supplier which
test within this range may well be on the way to posing a threat to the operations of the
laboratory. Several documented major exothermic reactions have occurred during the reduction
of peroxides in drums, bottles, cans and laboratory ware within this range.
>80 ppm - Any suspect container testing in excess of the limits of standard peroxide test strips
must be considered to be potentially shock sensitive. High peroxide concentrations may occur
without the presence of visible crystals. Also Read: activated alumina for water filtration.
Removal of Peroxides
Low concentrations of peroxides can generally be removed by filtering the contaminated material
through a column of chromatography-grade basic alumina. Several methods are available for the
"deperoxidation" of ether solvents; for a discussion, see Burfield, D. R. J. Org. Chem. 1982, 47,
3821.Also Read: Alumina Balls for Arsenic Removal
Overview Peroxide-forming chemicals are a class of compounds that have the ability to
form shock-sensitive explosive peroxide crystals. Many of the organic solvents
commonly used in laboratories have the potential to form explosive peroxide crystals.
Diethyl ether and tetrahydrofuran are two of the more common peroxide-forming
chemicals used today.
2. Therefore, it is extremely important that this procedure be followed regarding the
identification, handling, storage, and disposal of peroxide-forming chemicals. Peroxide
Formation Under normal storage conditions the materials listed in this document have the
potential to generate and accumulate peroxide crystal formations, which may violently
detonate when subjected to thermal or mechanical shock. Peroxide-forming chemicals
react with oxygen – even at low concentrations – to form peroxy compounds.
The risk associated with peroxide formation increases if the peroxide
crystallizes or becomes concentrated by evaporation or distillation.
Factors that affect rate of peroxide formation include exposure to air,
light and heat, moisture, and contamination from metals. Manufacturers
may add an inhibitor to peroxide forming chemicals to counter peroxide
formation. Don’t Miss this article: Gas Drying Activated Alumina is the Ultimate
Industrial Gas Purifier
For many peroxide-forming solvents, butylated hydroxy toluene (BHT) is commonly
added. BHT ‘scavenges’ oxygen in the solvent and prevents it from reacting with the
solvent to form peroxides. Over time, BHT or other inhibitor in the solvent can become
exhausted allowing peroxides to form.
Distilling the solvent can completely remove the BHT and make the solvent immediately
susceptible to peroxide formation. Peroxide crystals may form on the container plug or
the threads of the lid and detonate when the lid is twisted. Do not open a liquid organic
peroxide or peroxide-forming chemical if crystals or a precipitate are present.
Applicability This guidance information applies to all chemists and any other employee
who is involved with the packaging, inspecting, or using this type of laboratory
chemical/reagent. Definitions A peroxide is a chemical that contains a peroxo (O-O) unit,
one that has the chemical formula of O 2 ²¯.
These are shock sensitive compounds, can explode if subject to mechanical shock,
intense light, rapid changes in temperature, or heat. 2 Peroxide Forming Compound
Evaluation Protocol Upon discovering potential peroxide forming materials, do not
remove from the storage location until a thorough evaluation of the material has been
completed using the attached evaluation.
After the evaluation, review all information to make a decision based on the evaluation
criteria. If the compound is determined to be shippable, be sure to include the inspection
sheet in the packing envelope of the labpack container. If the material is deemed not
shippable, leave a copy with the generator discussing the potential hazards.
3. Bring the original back to the office. The account manager or operations manager will
prepare a quote for onsite handling.
Any material from the potential peroxide forming compound list can be approved for
transportation and disposal if the following conditions exist:
The container is unopened and the contents are unexpired
The container has been opened and the contents are unexpired or there is no expiration
date but the date of manufacture is present and the compound falls within the acceptance
parameters on the Recommended Storage Time Limits Table.
The inner container has been confirmed unopened (seal intact) full, contains an
inhibitor, the contents are expired, but the container is less than 3 yrs old and none of the
conditions exist.
The compound is on of the solid peroxide formers (potassium metal, potassium amide,
sodium amide, or sodium ethoxyacetylide) and is not discolored and has not formed a
crust on the surface.
Generator can confirm testing for peroxides with results of less than 8 ppm and the
testing falls within the timeframes for the groups. Performing the Visual Inspection
Solvents stored in glass bottles can be visually inspected for peroxides. Bottles containing
organic solvents are typically made of amber/brown glass, so a flashlight can be used to
light the interior of the bottle. During the inspection, you should look for 2 signs that the
material is contaminated:
Hard crystal formations in the form of ice like structures, crystals, solid masses or an
obscure cloudy medium signify gross contamination. 2. Wisp like structures floating in a
clear liquid suspension signify contamination. Use caution when performing the
inspection- peroxide formation may be present anywhere in the container:
The bottom of the container
The side of the containe
The threaded cap
The outside of the container Peroxide formation in ppm concentrations may not
be visually observable and must be identified through appropriate testing
procedures.
Employees should not open any containers that do not pass this evaluation
without the proper training, engineering controls, and PPE. Consult your HSE
Manager for further guidance