我应该如何报告物质中异构体的比例？

我应该如何报告物质中异构体的比例？

How should I report the ratio of isomers present in a substance?

通常，您应该在 IUCLID 第 1.2 节中分别报告每种异构体及其典型浓度、上限浓度和下限浓度。如果存在偏差，您可以在 IUCLID 第 1.2 节中将异构体报告为一个条目。当异构体以外消旋混合物的形式存在或异构体数量较多时，这种方法可能被认为是合适的。在这种情况下，您应该执行以下操作：在 IUCLID 第 1.2 节的相关字段中指定该条目所涵盖的异构体的总体典型浓度、上限浓度和下限浓度；在该条目可重复块的“备注”字段中注明异构体的相对比例。如果异构体的相对比例发生变化，则需要以范围的形式报告；在“偏差理由”字段中说明未单独报告特定异构体的原因。有关在 IUCLID 6 中报告物质身份的技术说明，请参阅手册中第 8.3.1-8.3.2 节，了解如何准备注册和 PPORD 档案。

You should normally report each individual isomer and their typical, upper and lower concentration levels separately in IUCLID Section 1.2. As a deviation, you may report the isomers under one entry in IUCLID Section 1.2. This approach may be considered appropriate when the isomers are present as a racemic mixture or when the number of isomers is large. In that case, you should do the following: Specify the overall typical, upper and lower concentration level of isomers covered by the entry in the relevant IUCLID Section 1.2 fields; Indicate the relative ratio of isomers in the "Remarks" field in the repeatable block for that entry. If the relative ratio of isomers varies, you will need to report it in the form of a range; Indicate why specific isomers have not been reported separately in the "Justification for deviations" field. For technical instructions on reporting the substance identity in IUCLID 6, see section 8.3.1-8.3.2 in the Manual on how to prepare registration and PPORD dossiers.