Study on the related substances of the raw materials and preparations of Gemfibrozil
OBJECTIVE To control the related substances in Gemfibrozil capsules.METHODS According to domestic and foreign standards,the related substances of Gemfibrozil API and preparations,were testd,and make statistical analysis of the results was performed.RESULTS A total of 143 batches of samples were taken from 6 manufacturers and the qualified rate was 100％according to the legal testing.However,the current regulatory standards cannot fully detect known and unknown impurities of Gemfibrozil.This study established a more specific impurity detection method and inferred two unreported impurities of Gemfibrozil trimer and isobutyl Gemfibrozil through mass spectrometry.Furthermore,the impurity sorbic acid was discovered migrating from the capsule shell to the drug.CONCLUSION This study further improves the related substances standards of Gemfibrozil API,controlls impurity A and impurity I,tightens the limit of single impurity and total impurity according to foreign pharmacopoeia,and increases the inspection items of related substances of Gemfibrozil capsules.
NETL
NSTL
万方数据
