CPMP ICH 283 95残留溶剂指南VIP专享

Annexesto:CPMP/ICH/283/95Impurities:Guidelineforresidualsolvents&CVMP/VICH/502/99Guidelineonimpurities:residualsolventsCPMP/ICH/283/95 杂质：残留溶剂指南&CVMP/VICH/502/99 杂质指南：残留溶剂附录Introduction 概述Thetwo(V)ICHresidualsolventsguidelines,ICHQ3CImpurities:Guidelineforresidualsolvents(CPMP/ICH/283/95)andVICHGL18Guidelineonimpurities:residualsolventsinnewveterinarymedicinalproducts,activesubstancesandexcipients(CVMP/VICH/502/99),havebeeninoperationforseveralyears,sinceMarch1998andJune2001respectively.两份(V)ICH 的残留溶剂指南：ICHQ3C 杂质：残留溶剂指南(CPMP/ICH/283/95)和 VICHGL18：杂质指南：新兽药制剂、活性成分和辅料中的残留溶剂(CVMP/VICH/502/99)已经分别自 1998 年 3月和 2001 年 6 月开始使用多年了。However,ithasbecomeevidentthatfurtherclarificationwasrequiredregardingthespecificationsforClass1andclass2residualsolventsinactivesubstances.但是，现在要求对活性物质中 1 类和 2 类残留溶剂的质量标准需要进行进一步的澄清。Aclearinterpretationoftheissuesregardingresiduesofsolventsusedinthemanufactureoffinishedmedicinalproducts,bothhumanandveterinary,wasalsorequired.同时也要求对制剂生产中使用的溶剂的残留问题进行清楚的阐述。AnnexI:Specificationsforclass1andclass2residualsolventsinactivesubstances附录 I：活性物质中 1 类和 2 类残留溶剂质量标准Specificationsforclass1solvents1 类溶剂质量标准InboththeICHandVICHguidelinesonimpurities:residualsolventsitisstatedthat“solventsinclass1shouldnotbeemployedinthemanufactureofdrug/activesubstances,excipients,anddrug/veterinarymedicinalproductsbecauseoftheirunacceptabletoxicityortheirdeleteriousenvironmentaleffect.However,iftheiruseisunavoidableinordertoproduceadrug/veterinarymedicinalproductwithasignificanttherapeuticadvanee,thentheirlevelsshouldberestrictedasshown,uniessotherwisejustified”.在 ICH 和 VICH 的杂质指南：残留溶剂中，已经说明了“在药品/活性物质、辅料和人药/兽药生产中不应使用 1 类溶剂，因为其毒性无法接受，或者因为其对环境有巨大的影响。但是，如果在生产一种有显著疗效的药品时不能避免，则应控制其...