Hubert B B
Drugs Standards Division, United States Pharmacopeial Convention Inc., Rockville, Maryland.
Drug Saf. 1990;5 Suppl 1:88-94. doi: 10.2165/00002018-199000051-00014.
The United States Pharmacopeia (USP) has developed policies on drug substance purity and organic volatile impurities. This paper will include the historical background and the scientific basis of these policies and will give several examples of how they are reflected in the tests that are included in USP monographs. Data on the types of analytical methods used in assessing the purity of compendial articles will also be presented.
美国药典（USP）已制定了关于原料药纯度和有机挥发性杂质的政策。本文将介绍这些政策的历史背景和科学依据，并给出几个例子说明它们如何体现在USP各论中包含的检测方法中。还将展示用于评估药典收载药品纯度的分析方法类型的数据。
