Comparison of the Quality of Domperidone Tablets Produced by Three Different Factories / 中国药房

ABSTRACT

OBJECTIVE:To compare the quality of domperidone tablets produced by 3 different factories METHODS:The quality of different products was investigated according to the standards of Ministry of Public Health and manufacture factories,including dissolubility,uniformity of dosage units,related substances and seals of blister packaging RESULTS:In 3 batches of products manufactured by Y,W and L,the contents of domperidone were 98 23%～99 74%,96 92%～98 31% and 97 42%～98 72%,and content uniformity A+1 8S was 2 11～3 38,3 97～5 25 and 5 49～7 47 respectively,which were in keeping with the Chinese pharmacopoeia;impurity R061668 was not found,and contents of impurity R052211 were 0 004%～0 024%,0 029%～0 072% and 0 003%～0 056%;the total impurity substances were 0 030%～0 095%,0 102%～0 128% and 0 232%～0 489%;the dissolubity(45min) was 95 09%～95 77%,91 25%～96 43% and 95 48%～96 58% respectively In experimental condition,no leakage was found from blister package of Y and W products,however,the leak rate of L product reached more than 38% CONCLUSION:According to this survey,the quality of product Y is the best,W is better