Impurity Profiling in Drug Development

Impurity-Profiling

Impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. In the pharmaceutical industry, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients, that arise out of … Read more

Impurities in Pharmaceutical Drug Substances

Impurities-in-pharmaceutical-drug-substances

Impurities are defined as foreign particle that affects the purity of a substance. Usually, impurities occurring in many pharmaceutical or medicinal preparations may be of the following types. 1) Types of pharmaceutical drug substances: There are several types of drug substances (Medicine) in the world of medicine like  The major, main and important content of the … Read more

Sources of Impurities in Pharmaceutical Substances

Sources of Impurities in Pharmaceutical Substances

The sources of impurities in pharmaceutical drug products and drug substances can be assigned to the drug substance or inert ingredients which are used for the formulation of a drug product. Sources of impurities can also be brought into the drug product during the formulation process or through contact with the packaging. The impurities formation … Read more

Types of Impurities in Pharmaceuticals

Types of Impurities in Pharmaceuticals

In the pharmaceutical industry, impurities may exist or develop in both API and formulation. The isolation, identification and quantification of these impurities are important for drug development and also for the regulatory requirement. The impurities present in APIs and finished products need impurity profiling to have control over quality. ICH (International Council for Harmonization) formulated … Read more

Effects of Impurities in Pharmaceuticals

Effects of Impurities in Pharmaceuticals

In pharmaceutical drug substances and drug products, impurities are developed during the synthesis. They remain with the active pharmaceutical ingredients (APIs) or sometimes develop during the formulation or upon the aging of both active pharmaceutical ingredients (API) and formulation of APIs to medicines. The consequences of impurities Impurities may bring about incompatibility with other substances; impurities may bring … Read more

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