chemical impurities synthesis

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asked Sep 26, 2021 in Cell Tracking by bocsci2018 (17,880 points)

Impurity profile studies play significant roles in active pharmaceutical ingredient (API) development, which are closely related to the quality, safety and efficacy of drug products. And the impurity profile of API for drug products requires studying in the view of stringent quality standards. The recent guidelines published by International Conference on Harmonization (ICH) recommended identification and characterization of all the impurities present at a level of ~0.10% or more.

chemical impurities synthesis

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