activedrugsubstancesandexcipientsorinthepreparationof drugproductstoenhancetheyield,increasesolubility,orfor crystallization(1–3).Althoughthesesolventsarecriticaltothe syntheticprocess,theyhavenotherapeuticvalueand,insome cases,maybetoxic.Thus,thesesolventsmustbeselectedcare- ...
suspected of other significant but reversible toxicities. Class 3 solvents: Solvents with low toxic potential- Solvents with low toxic potential to man; no health-based exposure limit is needed. Class 3 solvents have PDE's of 50 milligrams (mg) or more per day ...
由于1 类溶剂具有不可接受的毒性或会对环境造成危害,原料药、辅料及制剂生产中不应使用该类溶剂。但是,为了生产一种有显著治疗优势的制剂而不得不使用时,除非经过论证,否则应按表 1 进行控制。1,1,1-三氯乙烷因危害环境而列入表 1,其限度 1500ppm 是基于安全性数据而定的。 表1:制剂中的 1 类溶剂(应避免...
The stated limit of 1,500 ppm is based on a review of the safety data. Table 1. – Class 1 Solvents in Pharmaceutical Products (Solvents That Should Be Avoided) Solvent Concentration Limit Concern (ppm) Benzene 2 Carcinogen Carbon tetrachloride 4 Toxic and environmental hazard 1,2-...
Odor as an aid to chemical safety: Odor thresholds compared with threshold limit values and volatilities for 2 温馨提示: 1: 本站所有资源如无特殊说明,都需要本地电脑安装OFFICE2007和PDF阅读器。图纸软件为CAD,CAXA,PROE,UG,SolidWorks等.压缩文件请下载最新的WinRAR软件解压。 2: 本站的文档不包含任何...
(mg/day) Concentration Limit (ppm) Acetonitrile 4.1 410 Chlorobenzene 3.6 360 Chloroform 0.6 60 Cyclohexane 38.8 3880 1,2-Dichloroethane 18.7 1870 1,2- 10.9 1090 Dimethylacetamide N,N- 8.8 880 Dimethylformamide 1,4-Dioxane 3.8 380 2-Ethoxyethanol 1.6 160 215 仅供本次讲座学员使用,请勿上传分享。
ICH-Q3C-R5-残留溶剂指导原则.pdf,INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R5) Current Step 4 v