1.2 The nature and origin of the impurities in drug substances

Add time:07/24/2019    Source:sciencedirect.com

Publisher SummaryOrganic impurities, often called related, ordinary or synthesis-related impurities can originate from various sources and from various phases of the synthesis of bulk drugs and the preparation of pharmaceutical dosage forms. A sharp differentiation between synthesis-related or process-related impurities and degradation products is not always possible: degradation products can be formed during the synthesis and the isolation of the end-product and also upon storage of the bulk drug and especially during formulation and storage of the dosage form. As there are several possible synthetic routes for the preparation of the same drug material and in the case of generic drugs many of them can be in practical use, the set of the structures of possible impurities presented by the European Pharmacopoeia is in many cases far from being complete: different syntheses can give rise to other structures.

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