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质量控制分析方法:剂型的均匀性

Quality-control analytical methods: homogeneity of dosage forms.

作者信息

Kupiec Thomas C, Vu Nicole, Branscum David

机构信息

Analytical Research Laboratories, Oklahoma City, Oklahoma.

出版信息

Int J Pharm Compd. 2008 Jul-Aug;12(4):340-3.

Abstract

Content uniformity is the degree of consistency in the amount of the drug substance among dosage units. There are two ways to determine content uniformity according to United States Pharmacopeial Chapter 905: by means of Content Uniformity or Weight Variation methods. It is essenetial that compounding pharmacists know the different methods, how they work, and when to use each method to determine the content uniformity of their individual dosages.

摘要

含量均匀度是指各剂型单位中主药含量的一致程度。根据美国药典第905章,有两种测定含量均匀度的方法:采用含量均匀度测定法或重量差异测定法。至关重要的是,配方药剂师要了解不同的方法、它们的工作原理以及何时使用每种方法来确定其单个制剂的含量均匀度。

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