溶媒回收问题

秘制红烧肉

by Mr. Ting Siong Ang, CPIP - 5 December 2007 at 8:02 PM ET Typically, for recovery of solvents, to be used for intermediates & API, one can consider the following: 一般而言，对用于中间体和API的回收溶剂，可以考虑以下几点： 1. During validation, an analysis of the content of the waste solvent to determine the compounds within. Although this can be deduced from the manufacturing process itself, it is best to determine what are actually present within the waste solvents. More detail testing such as GCMS is required. 1.验证期间，分析废溶剂中的溶质，确定其中的化合物。虽然这可以从生产工艺本身推测出来，但最好能确定废溶剂中出现的物质。这要求更多的精密测试，比如GCMS（气相色谱质谱联用）。 2. Evaluation if the distillation column. The quality of the recovered solvent is as good as the distillation column used to recover it. This is typically determined by the analysis of recovered solvent itself to check if trace amount of the impurities in the manufacturing process are removed in the recovery or magnified instead. One will need to know the distillation column itself. i.e. refluc ratio, number of plates, fractional or simple distillation, etc......... 2.评估蒸馏柱。回收溶剂的质量取决于用于溶剂回收的蒸馏柱。通常通过回收溶剂本身的分析来确定生产过程中的痕量杂质是否在回收中除去或者增加了。你需要知道蒸馏柱本身的性质，比如，回流比，塔板数，精馏还是简单蒸馏，等等。 3. Establishment a specification for the recovered solvent. The specification for the recovered solvent may abe the same as the fresh solvent, as long as the rational is sound and well documented. Typically, the acceptance critieria for the recovered solvent gets more strict as we moved from intermedidates to API, and even within API, depending on the usage of the API (oral, inhalation, injections). 3.给回收溶剂建立一个质量标准。回收溶剂的质量标准可能与新溶剂一样，只要基本原理健全并良好地记录。通常，当我们从中间体转向API回收时，回收溶剂的可接受标准变得更加严格，即使在API中，也要依API的用途而定（口服、吸入、注射）。 4. Risk assessment and rational for specification is important. Risk assessment should include the evalution of the impurities present within the waste solvent, how these may be eliminated, if there are any magnification, if the recovery process can remove them and if the analytical testing can detect them. The risk assessment should consider the following factor of severity, likelihood and detectability. 4.风险评估和质量标准的合理性很重要。风险评估应包括出现在废溶剂中的杂质的评估，如何消除，杂质是否会放大，回收过程是否能除掉它们，分析测试是否能检测。风险评估应当考虑严重性、可能性和可检测性。

ptq518

这个好像早在ISPE中国区论坛上看到过呵呵

yuansoul

ptq518 发表于 2012-7-5 14:21
这个好像早在ISPE中国区论坛上看到过呵呵

那这个就属于复习了

LLL-蓬莱

好好学习啦！