1-Oxybisethane CH3CH2OCH2CH3 3 类 甲酸甲酯 Formic acid ethyl ester HCOOCH2CH3 3 类 甲酰胺 Methanamide HCONH2 2 类 甲酸 HCOOH 3 类 庚烷 n-Heptane CH3(CH2)5CH3 3 类 己烷 n-Hexane CH3(CH2)4CH3 2 类 乙酸异丁酯 Acetic acid isobutyl ester CH3COOCH2CH(CH3)2 3 类 乙酸异丙酯 ...
母指导原则:杂质:残留溶剂的指导原则 Q3C(R4)更新表 2、表 3 和附录 1,以反映对 N-甲基吡咯烷酮和四氢呋喃的 PDE 进行的修订。2009 年 2 月 对母指导原则所含异丙基苯的 PDE 信息的修订 修订母指导原则所含甲基异丁基酮的 PDE 信息,并纳入三乙胺的 PDE 更正了乙二醇的PDE信息 纳入2-甲基四氢呋喃(2-...
Table 2. – Class 2 Solvents in Pharmaceutical Products Solvent PDE (mg/day) Concentration Limit (ppm) Acetonitrile 4.1 410 Chlorobenzene 3.6 360 Chloroform 0.6 60 Cyclohexane 38.8 3,880 1,2-Dichloroethene 18.7 1,870 Dichloromethane 6.0 600 1,2-Dimethoxyethane 1.0 100 N,N-Dimethylacetamide 10.9 ...
谢谢。 1 “ICH指南在药品研发与生产中的应用” 2018年1月3 日 Class 1 Residual Solvents – 5 Solvents Concentration Solvent Concern Limit (ppm) Benzene 2 Carcinogen Toxic and Carbon 4 environmental tetrachloride Hazard 1,2-Dichloroethane 5 Toxic 1,1-Dichloroethane 8 Toxic 1,1,1- Environmental ...
activedrugsubstancesandexcipientsorinthepreparationof drugproductstoenhancetheyield,increasesolubility,orfor crystallization(1–3).Althoughthesesolventsarecriticaltothe syntheticprocess,theyhavenotherapeuticvalueand,insome cases,maybetoxic.Thus,thesesolventsmustbeselectedcare- ...
in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. Q3C(R5) Document History First History Date New Codification Codification Parent Guideline: Impurities: Guideline for Residual ...