包装和储存条件要点分析.docVIP

659 PACKAGING AND STORAGE REQUIREMENTS 659包装和储存要求 (Chapter to become official May 1, 2016) （本章节2016年5月1号正式生效） Delete the following： 以下内容删除： Every monograph in the USP and NF shall have packaging and storage requirements. For the packaging portion of the statement, the choice of containers is given in this chapter. For drug product packaging requirements, definitions are provided to guide selection and adaptation. For active pharmaceutical ingredients (APIs), the choice would be tight, well-closed or, where needed, a light-resistant container. For excipients, given their typical presentation as large-volume commodity items (containers ranging from drums to tank cars), a well-closed container is an appropriate default. 在USP和NF的每个专论中应要有包装和储存的要求。对于包装的声明部分，本章节提供了容器的选择。对于药品包装的要求，定义进行导向筛选和改编。对于API，要选择密封的、密闭性好的或者根据需要选择耐光的容器。对于赋形剂，和大容量商品一样，鉴于他们的典型性质，（容器从圆桶到罐车），默认是一个密闭性好的容器。 Where no specific directions or limitations are provided in the article’s labeling, articles shall be protected from moisture, freezing, and excessive heat and, where necessary, from light during shipping and distribution. Drug substances are exempt from this standard. USP38. 在物品的标签上没有提供特定的方向或局限性。物品在运输和配送过程中应该防潮、防冻、防过热，必要时要避光。药物不受这个标准限制。 PACKAGING包装 Packaging must not interact physically or chemically with official articles in any way that causes their safety, identity, strength, quality, or purity to fail to conform to requirements. 包装不能以任何方式使物品化学和物理方面产生相互影响，从而导致他们的安全性、特性、强度、质量或纯度不符合要求。 Packaging container choices are given in this chapter. For drug products and active pharmaceutical ingredients (APIs), the container choices are tight, well-closed, or, where needed, light-resistant. For excipients, given their typical presentation as large-volume commodity items (containers ranging from drums to tank cars), a well-closed container is an appropriate default. For articles other than drug substances and drug products, where no specific directions or limitations are provided, articles shall be protected f