Inorganic Chemistry (02) = Types & Sources of Impurities in Pharmaceutical Products | Impurities

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Contents for 1st Unit of Inorganic Chemistry -
Impurities in pharmaceutical substances: History of
Pharmacopoeia, Sources and types of impurities, principles involved in the
limit test for Chloride, Sulphate, Iron, Arsenic, Lead and Heavy metals,
modified limit test for Chloride and Sulphate
Types & Sources of Impurities in Pharmaceutical Products
An impurity in pharmaceuticals is classified as any component that is not the entity defined as the drug substance. In addition, for a drug product, any component that is not a formulation ingredient is considered an impurity.
Sources of Impurities in Pharmaceuticals
The different sources of impurities in pharmaceuticals are listed below:
1) Raw material used in the manufacture.
2) Reagents used in the manufacturing process
3) Method/ process used in manufacture or method of manufacturing
4) Chemical processes used in the manufacture
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
There are three different types of impurities in pharmaceuticals that API manufacturing companies must be wary of.
Organic Impurities
Organic impurities are often process-related or drug-related pharmaceutical impurities. These types of contaminants are most likely to arise during the synthesis, purification, and storage of the drug substance. Organic volatile impurities are residual solvents that are produced during the synthesis of drug substances or in excipients used in the production of drug formulations. A few examples include starting materials, by-products, intermediates, degradation products, reagents, ligands, and catalysts.
Inorganic Impurities
Inorganic impurities often derive from the manufacturing process. These impurities are often reagents, ligands, catalysts, heavy or residual metals, inorganic salts, filter aids, or charcoals. Inorganic contaminants can be detected and quantified using pharmacopeial standards.
Residual Solvents
The third type of impurity in pharmaceuticals is residual solvents. These impurities are residuals of solvents present in the manufacturing process. Solvents used in pharmaceutical manufacturing are defined by three classes based on their toxicity. Class one solvents should always be avoided, as they are known to be human carcinogens or environmentally hazardous. Class two solvents should have limited use, as some levels of harmful toxicity may be present. Class three solvents have low toxic potential to humans and do not need a limit.
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