国家药品标准物质研制技术要求的介绍

Introduction of general guidance for the national pharmaceutical reference standards

药品标准物质是药品质量分析中使用的实物对照,也是药品检验不可缺少的物质。为保证药品标准物质量值的准确性、保障供应,中检所多年来积累了丰富的经验,并制定了详细的技术要求,现将主要工作流程及研制要求进行介绍,供我国药品质量监管、检验及研发机构人员参考。

Pharmaceutical reference standards are required by pharmacopoeia testing and pharmaceutical control in general.NICPBP is responsible for the establishment and distribution of national pharmaceutical reference standards.During 50 years＇ research,nowadays NICPBP has rich experience on reference standards,established particular technical specifications.This article introduced the general technical guidance on the source of candidate,evaluation,assignment of content,maintenance and distribution of national pharmaceutical reference standards.