摘要
药品标准物质系指用于药物及其制剂的鉴别、检查、含量测定的标准物质。在新药开发过程中 ,需要标定自己的药品标准物质。本文介绍了工作用药品标准物质的特性 ,量值溯源 -传递体系 ,标定方法及其正确的使用方法。
Pharmaceutical reference materials (PRM) refer to the standard materials used in tests for identification, purity and assay of pharmaceuticals. PRM should be determinated during new drug development and research. The characteristics, traceability and transferability of PRM were introduced. The methods of determination and usage were also reviedwed.
出处
《上海计量测试》
2002年第2期18-20,共3页
Shanghai Measurement and Testing
