Monographs 各论

1. Monographs set forth the article's name, definition, specification, and other requirements related to
packaging, storage, and labeling.
1、 各论中阐述了产品的名称、定义、质量标准以及其他与包装、储存和贴签相关的要求；
2. The specification consists of tests, procedures, and acceptance criteria that help ensure the identity, strength, quality, and purity of the article.
质量标准由试验、测定法和验收标准组成，用以确保产品的均一性、规格、质量和纯度符合标准
3. For general requirements relating to specific monograph sections, see section 5, Monograph Components.
具体各论部分相关的通用要求，参见各论组分第5节；
4. Because monographs may not provide standards for all relevant characteristics, some official substances may conform to the USP or NF standard but differ with regard to nonstandardized properties that are relevant to their use in specific preparations.
4、 各论中可能不包含所有相关性状的标准，因此一些法定原料药可能符合USP或NF标准，但用于特殊制剂时，相关的非标准性质可能不符合USP或NF的要求；
5. To assure interchangeability in such instances, users may wish to ascertain functional equivalence or determine such characteristics before use.
5、 为确保上述情况的互换性，使用者应在使用前确定互换前后功能等效或测定上述特性。