药典检验与监管指南
药物赞助人和申请人在申请中应提供辅料、原料药和成品药的标准（即属性、分析程序和合格指标）。
这些标准应符合美国药典/国家处方(USP/NF)、英国药典(BP)、欧洲药典(EP)或日本药典(JP)的质量标准。
药典检验是许多原料药和成品药的标准检测方案。进行检验并符合药典方法所述标准，是原料药和成品药在全球生产、放行和发运的基本要求。
立即与专家交流，获得有关药典检验及遵守监管要求方面的进一步支持。
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相关资源
- Flyer: A Quick Guide to Successful Dissolution Testing
From development to drug release, this interactive PDF outlines a range of reliable, consistent filters and reagents for dissolution testing protocol.
- Poster: HPLC Packings for USP Compendial Methods
HPLC USP columns wallchart
相关网络研讨会
本演示文稿高度概况了药典标准的具体价值。
了解通过灵活调整U/HPLC方法提高药物分析效率、降低成本的策略。
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