Calibration of the 1st Batch of National Reference of Promestriene
OBJECTIVE To prepare and calibrate the first batch of national standard(NS)of pormestriene for the sake of fulfil-ling 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 meth-ods,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.CON-CLUSION 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.
national reference materialpromestrienestructural confirmationmass balance methodcontent
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