USP 659 包装和储存要求 dry place理解

昕悦传奇

各位同仁，有个关于USP <659>package and storgae requirement 中一句话的理解：
我这边有个美国药典的原料用于药品生产，他的储存条件写着是 store in dry place ,根据美国药典凡例 10.10 packageing and storage：all articles in USP or NF are subject to the packaging and storage requirement specified in package and storgae requirement <659>,unless different requirments are provide in an individual monograph
所以查看了在美国药典659章节，dry place 有定义：Dry place；A place that does not exceed 40% average relative humidity at 20℃ or the equivalent water vapor pressure at other temperatures ..........

看了一下这个659章节的 introduction: the purpose of this chapter is to provide packaging definitions,auxiliary packaging information ,and storage condition definitions revlevant to the storage and distribution of active ingredients,excipients and medical products, such as pharmaceuticals,devices,combination products(e,g,drug-eluting stents),and dietary supplement （根据这个introduciton ,我这边的这个原料应该需要follow这个章节）
但是，在这个659章节下面的 Temperature and storge 下，描述的这么一段话，尤其是最后一句Drug substances are exempt from this standard
Specific directions are stated in some monographys with respect to storage conditions(e,g,the temperature or humidity at which an article must be stored and shipped ,such directions apply except where the labe on the article has different storage conditions that are based on stability studies ,where no specific directions or limitations are provided in the article's labeling ,articles must be protected from mositure,freezing,and excessive heat,and,where necessary,from light during shipping and distrubtion ,Drug substances are exempt from this standard

现在我有些困惑：
1.最后一句Drug substances are exempt from this standard 写着不要需要遵守这个标准，那Dug susbtance 具体指哪些
2.articles和dru susbtance 区别在哪里
3.用于药品生产的符合美国药典的原料，如果储存条件写着 store in dry place ，是否需要follow 659章节下的dry place 有定义
谢谢

小金库

感谢分享。

罗伊鲱

exempt from “this standard”是指“articles must be protected from mositure,freezing,and excessive heat,and,where necessary,from light during shipping and distrubtion”
articles是指active ingredients（就是Drug substances）, excipients and medical products