国外专家现在关心二类、三类溶剂中一类溶剂（如苯、四氯化碳）的残留，哪些溶剂中含有一类溶剂？难道每个一类溶剂都要排除一下？这样工作量太大了
一类溶剂包括苯、四氯化碳、1,2—二氯乙烷、1,1—二氯乙烯、1,1,1—三氯乙烷等。试验过程中用到哪些一类溶剂就要检测其残留，规定限度。
我的意思是其他类溶剂中残留一类溶剂，当然，工艺中没有用到一类溶剂。
ANNEX I: SPECIFICATIONS FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS IN ACTIVE SUBSTANCES
下载地址如下：Annexes to Impurites GL - Specifications for Residual Solvents
A Class 1 solvents used as starting materials
B Class 1 solvents present as an impurity
Where a Class 1 solvent might be present in another solvent (e.g. toluene or acetone
containing benzene), a routine test for this Class 1 solvent, on a suitable intermediate or on
the final active substance, is not required when:
? the limit applied to the originator solvent is such that the Class 1 solvent will be present
in the active substance at levels below the limits set out in the guideline, taking into
account the maximum likely level of contamination of the Class 1 solvent. The
volatility of both solvents in the drying processes must be taken into account when
applying this argument.
? it is demonstrated with a validated method that the Class 1 solvent is not more than
30 % of the specified limit, in a suitable intermediate or in the final active substance.
Supporting data should be presented on 6 consecutive pilot scale batches or 3
consecutive industrial scale batches.
? The specification for the originator solvent used includes a routinely performed test and
limit for the Class 1 solvent.
SPECIFICATIONS FOR CLASS 2 SOLVENTS
A Class 2 solvents used in the last step of the synthesis
B Class 2 solvents used prior to the last step of the synthesis
不好意思，英语不好，我翻译一下：
在以下情况时，当一类溶剂存在于其它溶剂，比如甲苯和丙酮中含有苯，对中间体或API中的一类溶剂常规检测不作要求。
1、API中含有一类溶剂的来源溶剂的限度低于指南中的规定时，考虑一类溶剂污染的最大可能的水平。溶剂在干燥时的易挥发性需要考虑。
2、已经被证实：在中间体或API中，一类溶剂的残留不超过特定限度的30%。需要连续的6批中试规模或3批工业规模的数据支持。
3、来源溶剂的质量标准包括对一类溶剂的常规检测。
对于第一条如何理解？望不吝赐教
根据该1类溶剂在来源溶剂中的最大可能的水平是多少，然后所设定的来源溶剂的限度可以保证其所含的该1类溶剂的限度远低于指南的要求，则可以免除例行检测。
一类溶剂包括苯、四氯化碳、1,2—二氯乙烷、1,1—二氯乙烯、1,1,1—三氯乙烷等。试验过程中用到哪些一类溶剂就要检测其残留，规定限度。
我的意思是其他类溶剂中残留一类溶剂，当然，工艺中没有用到一类溶剂。
ANNEX I: SPECIFICATIONS FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS IN ACTIVE SUBSTANCES
下载地址如下：Annexes to Impurites GL - Specifications for Residual Solvents
A Class 1 solvents used as starting materials
B Class 1 solvents present as an impurity
Where a Class 1 solvent might be present in another solvent (e.g. toluene or acetone
containing benzene), a routine test for this Class 1 solvent, on a suitable intermediate or on
the final active substance, is not required when:
? the limit applied to the originator solvent is such that the Class 1 solvent will be present
in the active substance at levels below the limits set out in the guideline, taking into
account the maximum likely level of contamination of the Class 1 solvent. The
volatility of both solvents in the drying processes must be taken into account when
applying this argument.
? it is demonstrated with a validated method that the Class 1 solvent is not more than
30 % of the specified limit, in a suitable intermediate or in the final active substance.
Supporting data should be presented on 6 consecutive pilot scale batches or 3
consecutive industrial scale batches.
? The specification for the originator solvent used includes a routinely performed test and
limit for the Class 1 solvent.
SPECIFICATIONS FOR CLASS 2 SOLVENTS
A Class 2 solvents used in the last step of the synthesis
B Class 2 solvents used prior to the last step of the synthesis
不好意思，英语不好，我翻译一下：
在以下情况时，当一类溶剂存在于其它溶剂，比如甲苯和丙酮中含有苯，对中间体或API中的一类溶剂常规检测不作要求。
1、API中含有一类溶剂的来源溶剂的限度低于指南中的规定时，考虑一类溶剂污染的最大可能的水平。溶剂在干燥时的易挥发性需要考虑。
2、已经被证实：在中间体或API中，一类溶剂的残留不超过特定限度的30%。需要连续的6批中试规模或3批工业规模的数据支持。
3、来源溶剂的质量标准包括对一类溶剂的常规检测。
对于第一条如何理解？望不吝赐教
根据该1类溶剂在来源溶剂中的最大可能的水平是多少，然后所设定的来源溶剂的限度可以保证其所含的该1类溶剂的限度远低于指南的要求，则可以免除例行检测。