主题：【求助】鉴定阈和界定阈翻译

原文由 sosobear 发表:
帮忙一下：
1. 对于注册资料质量标准中的杂质分类，有特定的、非特定的杂质和确定的、非确定的杂质，此处对于确定和特定如何理解。
2. 对于杂质阈值中的鉴定阈值和界定阈值又是如何定义划分的。
还有其对应的英语？

Identified impurity: an impurity for which structural characterisation has been achieved.
鉴定的杂质：结构特征已经被确定的杂质。
Unidentified impurity: an impurity for which a structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (for example, relative retention).
未鉴定的杂质：结构特征未确定但根据分析特性被定义的杂质（如按相对保留时间对杂质定位）。
Specified impurity: an impurity that is individually listed and limited with a specific acceptance criterion in a monograph. A specified impurity can be either identified or unidentified.
指定的杂质：专论中单独列出并规定了限度的杂质。指定的杂质可能被鉴别也可能未被鉴别。
Unspecified impurity: an impurity that is limited by a general acceptance criterion and not individually listed with its own specific acceptance criterion.
未指定的杂质：规定了一个总的可接受标准，但未单独被列出的杂质。
鉴定阈值(Identification threshold): 超过此值的杂质必须做结构鉴别。
界定阈值(Qualification threshold): 超过此值的杂质须做毒理试验，要有足够的毒性数据。

谢谢