Katori N
Eisei Shikenjo Hokoku. 1994(112):200-1.
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.
重量差异和含量均匀度测试均旨在确保剂量单位的均匀性。在《日本药局方》中，第13版对这些测试提出了修改建议，并基于统计学考虑引入了新的概念。变更要点如下：1. 引入变量要求；2. 重量差异和含量均匀度测试抽样方案的匹配；3. 含量均匀度测试应用条件的阐明；4. 质量标准基于偏离标签标示量而非样品均值。
