myreebok
第3楼2009/06/19
If Class 1 solvents are likely to be present, they should be identified and quantified.
"Likely to be present" refers to the solvent used in the final manufacturing step and to solvents that are used in earlier manufacturing steps and not removed consistently by a validated process.
这段话就很说明问题,ICH规定3类只要干失小于0.5但1,2类并不是不能出现。
影子
第6楼2009/06/19
您可能还没明白我的意思,现在假设在整个工艺中没用使用一、二类溶剂,只在最后精制步骤用到了乙醇,那么乙醇的残留是用干燥失重控制呢还是用验证的方法(药典专论中没有规定具体的方法)进行控制?
影子
第8楼2009/06/19
Only Class 3 solvents are likely to be present. Loss on drying is less than 0.5%.
我看这话的意思是干燥失重就可以了?
我们有两台顶空,关键验证起来太麻烦......