RESUMO
Objective To research the nevirapine-related substances method in the second supplement of Chinese Pharma-copoeia(Ch.P) 2010 edition, and explore the existing problems. Methods In-depth comparison of the nevirapine-related substances test method in Ch.P, United States Pharmacopoeia(USP) and European Pharmacopoeia(EP);three consecutive batches of nevirapine produced at a pharmaceutical factory were detected, and inspection situation of the related substances was compared. Results According to the Ch.P method we detected three impurities, while according to the other two pharmacopoeias we detected four impu-rities. Ch.P leaves out the biggest single impurity. Conclusion We proved that the second supplement of Ch.P 2010 edition has the problem of residual impurities in the nevirapine-related substances test method, and propose to revise the nevirapine-related sub-stances method.
RESUMO
Objective To research the nevirapine-related substances method in the second supplement of Chinese Pharma- copoeia(Ch.P) 2010 edition, and explore the existing problems. Methods In-depth comparison of the nevirapine-related substances test method in Ch.P, United States Pharmacopoeia(USP) and European Pharmacopoeia(EP) ; three consecutive batches of nevirapine produced at a pharmaceutical factory were detected, and inspection situation of the related substances was compared. Results According to the Ch.P method we detected three impurities, while according to the other two pharmacopoeias we detected four impu¬rities. "Ch.P" leaves out the biggest single impurity. Conclusion We proved that the second supplement of Ch.P 2010 edition has the problem of residual impurities in the nevirapine-related substances test method, and propose to revise the nevirapine-related sub¬stances method.