USP药品质量标准.pptVIP

* * * * Example: Pioglitazone Monograph in PF36（1）举例：吡格列酮各论,收录于PF36（1） 第三十一页，共45页。 Reference Standard Development标准品开发 Material is tested and characterized through collaborative testing involving a minimum of three labs—industry, FDA, and USP (3 months) 物料在至少3个实验室进行联合标定-企业，FDA和USP Bulk material is obtained from industry 从企业获取原料 Data from the collaborative study are reviewed by USP staff scientists ( 1week) USP科学人员审核联合标定数据 Compilation of collaborative study is reviewed and balloted by USP scientific teams (3 weeks) USP科学小组审核联合标定汇总数据并投票 Once approved, material subdivided, labeled QC (1-2 m