Guideline on setting specifications for related impurities in antibiotics
Table of contents 目录
Executive summary概要......................................................................................………………...3
1. Introduction (background)介绍（背景）................................................................................... 3
2. Scope 范围................................................................................................................................... 4
3. Legal basis 法规依据.................................................................................................................. 4
4. General requirements一般性要求..............................................................................................5
5. Impurity profiling and reporting, identification and qualification thresholds 杂质概况和报告限，鉴定限和界定限 ................................................................................................................6
5.1. Active substances manufactured by semi-synthesis 半合成法生产的活性物质......................6
5.2. Active substances manufactured by fermentation, single compound发酵法生产的活性物质，单一化合物........................................................................................................................................7
5.3. Active substances manufactured by fermentation, family of compounds 发酵法生产的活性物质，同族化合物............................................................................................................................7
5.4. Peptides manufactured by fermentation/semi-synthesis发酵法和半合成法生产的多肽........7
5.5. Active substances for veterinary use 兽用活性物质.................................................................7
5.6. Special cases for very complex impurity profiles非常复杂的杂质概况特例..........................7
6. New applications and variations 新申请和不同情况.............................................................. 8
6.1. New active substances新的活性物质........................................................................................8
6.2. Existing active substances, not subject to a Ph. Eur. monograph 无EP专论的活性物质........8
6.3. Active substances subject to a Ph. Eur. monograph 有EP专论的活性物质............................8
6.3.1. Existing active substances subject to a Ph. Eur. monograph with transparency
statement and availability of a CRS for peak identification or relative retention times for the
related substances有EP专论，有透明度声明和峰鉴别对照品或有关物质相对保留时间的活性物质................................................................................................................................................8
6.3.2. Existing active substances subject to Ph. Eur. monograph, with transparency statement, but no availability of a CRS for peak identification or relative retention times for the related substances有EP专论，有透明度声明但无峰鉴别对照品或有关物质相对保留时间的活性物质........................................................................................................................................................8
6.3.3. Existing active substances subject to Ph. Eur. monograph, without transparency
statement 有EP专论，无透明度声明的活性物质..........................................................................9
6.3.4. Revision of Ph. Eur. monographs EP专论的修改............................................................
..... 9
settings中文意思7. Specifications for medicinal products药物产品的标准............................................................9
8. Analytical procedures分析方法................................................................................................10
Definitions定义...............................................................................................................................10
References 参考文献.....................................................................................................................11
Annex 1: Explanatory note regarding thresholds附录1：有关限度的注释..............................12
Annex 2: Thresholds附录2：限度.................................................................................................13
Annex 3: Example of “fingerprint chromatogram” approach to control very complex impurity profiles 附录3： “指纹图谱”方法来控制非常复杂的杂质概况的示例....................14
Executive summary 概要
（略）
1.Introduction (background) 介绍（背景）
（略）
2.Scope （范围）
本指南提供上市批准申请中，设定抗生素（如抗菌物质）的有关杂质的指导意见，这些抗生素是发酵产品或由发酵产品衍生的半合成物质。进一步将该指南的范围扩大，使其能应用于其它抗生素（如抗真菌物质）是可预见的。
本指南给出的原则是关于活性物质中和药物产品中有关物质含量和界定方面的，不应用于临
床试验中使用的研究物产品中使用的新活性物质。
本指南中，给出的是有关杂质的报告限、鉴定和界定限。对于由相近的有关化合物的混合物构成活性物质的抗生素，可能难以应用本指南的通用限度。本指南给出了如何设定限度和质量标准和如何界定杂质概况的一般性原则。这些限度代表了一般性行的设定要求，这些限度是可以调整的，以适合特定的情况。必要的时候，需要考虑到安全性的进一步要求。
本指南不包括来自发酵过程的产物，例如，微生物的残留物，培养基，基质和前体；这包括在EP的通用专论“发酵产品”中。（该专论只适用于发酵生产的物质，不适用于半合成法生成的物质）