Study on content uniformity of three constituents in Metronidazole,Clotrimazole and Chlorhexidine Acetate Suppositories from different factories
CHEN Tong
LIANG Yi
Abstract:Objective To study the content uniformity of three constituents in metronidazole,clotrimazole and chlo-rhexidine acetate suppositories from different factories. Methods Content uniformity of fourteen batches from fourteen dif-ferent factories was detected according to HPLC method from Chinese Pharmacopeia(edition 2010,Part 2). Results Three Kinds of ingredients content uniformity of nine manufacturers consistented with the standard. The qualification rate was 64. 3%. Some Kind of ingredients content uniformity was irregularity in part of manufacturers. Conclusion To maKe sure the efficient and safety of clinic medicine,it was recommended that the manufacturers should taKe process validation and multiple - point monitoring in productive process. Also it was necessary to add content uniformity investigation in supposito-ries inspection standard.
Keywords:MetronidazoleClotrimazole and Chlorhexidine Acetate SuppositoriesContent uniformityClotrimazoleChlorhexidine acetate
Publication Date:2015-01-01
Online Publishing Date:2025-08-15(First online date of this platform, not the publication date of the document)
Pages:3( 517-518,555 )
