External Reference Standards or Relative Response Factors: Considerations for Quantitation of Impurities in Pharmaceuticals

Accurate and reproducible quantitation of impurities in pharmaceuticals is an important part of drug development. Impurities must be controlled to levels that will ensure the quality of the product is as good or better than the quality of materials used in preclinical safety studies and clinical tri...

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Bibliographic Details
Main Author: article Editorial
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2021-08-01
Series:Разработка и регистрация лекарственных средств
Online Access:https://www.pharmjournal.ru/jour/article/view/991
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