Guideline on setting specifications for related impurities in antibiotics中文.doc

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.......................................................................................