关于固体制剂中的残留溶剂检测大家怎么看？

windforce

实际情况：U.S 片剂ANDA申报。

固体制剂例如包衣，造粒中使用溶剂情况比较多。 国内多数企业是不测，公司有人建议以验证三批测下结果，都达标的话后续不测，但貌似法规上行不通。

欧盟指南 CPMP/ICH/283/95 Impurities: Guideline for Residual Solvents &CVMP/VICH/502/99 Guideline on Impurities: Residual Solvents

SPECIFICATIONS FOR FINISHED PRODUCTS WHEN ORGANIC SOLVENTS HAVE BEEN USED IN THEIR MANUFACTUREA
test for organic residues of solvents that are used in the manufacture of finished products
should be included in the product specifications. Process validation results are not considered
to adequately justify the omission of such a test from the specifications, but they can be used
to justify skip testing.

If Class 3 solvents only are used, routine testing by loss on drying with a < 0.5% acceptance
limit is acceptable when this test is appropriately validated for determination of the relevant
solvent(s). Where residues of Class 3 solvents cannot be reduced to this level and/or where
Class 2 solvents are used in the production, specific (chromatographic) techniques should be
used.

各位同行，你们的制剂生产对溶剂残留是如何把控的？（特别是出口）

hongwei2000

FDA在09还是10年专门出文要求的，按照Option1和Option2判定，必要时进行检验。对于上市、在注册和等注册产品的要求，非常明确。国内远达不到那水平，而且对残留溶剂的认识，尤其是引入的（不是加入的）还处在无知状态，所以国内企业验证批做了的都已经是好的。

beiwei5du

hongwei2000 发表于 2013-6-24 18:43
FDA在09还是10年专门出文要求的，按照Option1和Option2判定，必要时进行检验。对于上市、在注册和等注册产 ...

相关的文章在哪里呢？？hongwei老师！

hongwei2000

beiwei5du 发表于 2017-7-29 14:26
相关的文章在哪里呢？？hongwei老师！

Option应该在ICH Q3C里就有
FDA的要求可以搜一下FDA官网