Applicability of Test Procedures 检验规程的适用性
1. A single monograph may include several different tests, procedures, and/or acceptance criteria that reflect attributes of different manufacturers' articles.
1、 品种项下可能包含几个不同的试验、测定法,和/或验收标准,而从验收标准中科分辨不同制造商产品的质量特性。
2. Such alt-ernatives may be presented for different polymorphic forms, impurities, hydrates, and dissolution cases. Monographs indicate the tests, procedures, and/or acceptance criteria
to be used and the required labeling.
2、 可使用其他方法,用于不同的晶型、杂质、水合物、溶出度。各论中给出需要使用的试验、测定法和/或验收标准,以及贴签的要求。
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