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The presence of impurities, particularly the API-related impurities, i. Since the regulatory requirements and management strategies are required to be established and complied, sources of impurities shall be carefully classified prior to take subsequent steps such as development of analytical methods and acceptance criteria. Current international regulatory requirements for the management of impurities in pharmaceuticals were reviewed. Procedures for the identification of DPIs in pharmaceuticals, i. Impurities in drug substance i.


Analysis and impurity identification in pharmaceuticals




Analysis and impurity identification in pharmaceuticals
Impurity is not a much-liked word by pharmaceutical and industry people, because they are concerned about quality. Here we discuss various impurities that might be present in API formulations. As the impurity present in a drug can affect its quality and thus its efficiency, it is therefore crucial to know about impurities. The current article reveals the different terms, regulatory control, and basic techniques e. This article primarily focuses on identification and control of various impurities i. For any of the substances, quality is the prime objective.



Determination of Impurities in Pharmaceuticals: Why and How?
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