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Pharmacopeia Standard Samples and Their Practical Application in the National Drug Standardization System

机译:药典标准样品及其在国家药品标准化体系中的实际应用

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摘要

Standard samples constitute one of the key elements in the medicines standardization system. In pharmacopeia analysis in the Russian Federation and many foreign countries, the use of standard samples is regulated by the corresponding normative documents and pharmacopeia monographs. There are different classifications for standard samples and, depending on purpose, certification programs. Standard samples used in compliance with the requirements of pharmacopeia articles or monographs in international, regional and national pharmacopeias are generally termed pharmacopeia standard samples.
机译:标准样品是药品标准化体系中的关键要素之一。在俄罗斯联邦和许多其他国家的药典分析中,标准样品的使用受相应的规范性文件和药典专论的约束。标准样品和认证程序有不同的分类,具体取决于目的。符合国际,地区和国家药典中药典条款或专着要求的标准样品通常称为药典标准样品。

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