首批普罗雌烯国家标准物质标定

Calibration of the 1st Batch of National Reference of Promestriene

目的为满足国内普罗雌烯及相关制剂质量控制的需要,研制并标定首批普罗雌烯国家标准品。方法采用高分辨质谱、核磁共振波谱、红外光谱以及紫外光谱对待标品进行定性及结构确认;对待标品进行了理化分析;根据不同国家药品标准方法分别对待标品进行了纯度分析,通过质量平衡法进行赋值,并通过核磁定量进行验证,并对待标品的均匀性和稳定性进行了考察。结果待标品与普罗雌烯同质,经质量平衡法赋值含量为99.6%;均匀性考察符合要求;本品应在10~30℃保存,遮光、密封。结论本批待标品确认为普罗雌烯,以C_(22)H_(32)O_(2)计,含量为99.6%,可以作为首批普罗雌烯国家标准品,可作为普罗雌烯及相关制剂鉴别和含量测定用对照品。

OBJECTIVE To prepare and calibrate the first batch of national standard(NS)of pormestriene for the sake of fulfilling the requirement of quality control on it and related drug products in domestic.METHODS The structure of candidate pormestriene was confirmed by MS,NMR,IR and UV.Physical-chemical analysis was carried out.According to different national drug standard methods,the purity of the candidate was determined,the value was assigned by mass balance method,and the uniformity and stability of the candidate were investigated.RESULTS The candidate was homogenous with promestriene,and the content was 99.6% measured by mass balance method.Uniformity inspection met the requirements.The product should be stored at 10-30℃,shaded and sealed.CONCLUSION The candidate was confirmed to be promestriene,which can be used as the first national standard,the content is 99.6%,and it can be used as a reference for the identification and content determination of promestriene and related preparations.