内容介绍

微谱生物医药·杂质研究中心作为行业前沿的一体化分析测试平台，拥有国际尖端的大型精密仪器设备、专业的研发团队、先进的分析及解析技术,通盖药品研制各阶段的分析需求,精准助力药品国内外申报，目前已帮助国内500多家药企完成了1000多个品种的注册申报工作。从研发到生产，从原料药到制剂,从IND到NDA,我们会更快更好为您提供评估报告,方法开发验证报告和分析测试结果。

法规及指导原则

o ICH O2(R1)Validation of Analytical Procedure:Text and Methodology

o ICH O3A(R2)lmpurities in New Drug Substances

o ICH O3B(R21lmpuritiesin New Drug Products

oICH O3C(R7Maintenance of the Guideline for Residual Solvents

oICH 06A Specifications:Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances0ICH M7R1) Assessment and Control of DNA Reactive(Mutagenic) lmpurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

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ICH O3D(R1)Implementation of Guideline for ElementalImpurities

Pharmacopoeia of the People's Republic of China

The United States Pharmacopoeia

0European Pharmacopeia

0British Pharmacopoeia