原文由 myreebok 发表:
对于残留限度 ICH已经有明文规定了,但是作为制药企业来说,制订限度能更好控制产品质量,对化学API来说,最后纯化溶剂是需要制订残留限度的
原文由 myreebok 发表:
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。
原文由 myreebok 发表:
好的,我马上把要求贴出来
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?
原引自ICH Q3c R3 3.5。
兄弟苦了你了,想当年偶也写过,及其凄惨。。。
不过兄弟劝你一句,有时间最好做下GC限度验证,顶空又不是很贵。。。欧洲人很挑剔的,换句话说,那叫时尚