[Statistical considerations for weight variation and content uniformity tests].

N Katori
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Abstract

Weight variation and content uniformity tests are both intended to ensure the uniformity of dosage units. In the Japanese Pharmacopoeia, modifications to these tests have been proposed in thirteenth revision with new concepts based on statistical considerations. The points of change are as follows: 1. introduction of a variables requirement, 2. matching of sampling plans of weight variation and content uniformity tests, 3. clarification of conditions for application of content uniformity tests, 4. criterion of quality based on deviation not from the sample mean but from the label claim.

[重量变化和含量均匀性试验的统计考虑]。
重量变化和含量均匀性试验都是为了保证剂量单位的均匀性。在日本药典中,在第13次修订中提出了基于统计考虑的新概念,对这些测试进行了修改。变化点如下:1。引入变量要求,2。2 .重量变化取样方案与含量均匀性试验方案的匹配;3 .澄清含量均匀性试验的应用条件。质量标准不是基于样本平均值的偏差,而是基于标签声明的偏差。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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