IMPURITY

Impurities in pharmaceuticals are the unwanted chemicals that remain with the active pharmaceutical ingredients (API’s) or develop during formulation or upon aging of both API and formulated API’s to medicines.

The different pharmacopoeias such as British Pharmacopoeia (BP) and the United States Pharmacopoeia (USP) are slowly incorporating limits to allowable levels of impurities present in the API’s.

Impurity profiling is very important during the synthesis of drug substances and manufacture of dosage forms, as it can provide crucial data regarding the toxicity, safety, various limits of detection, and limits of quantitation, of several organic and inorganic impurities, usually accompany with bulk drugs and finished products.

 

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