Quality of cefotaxime sodium preparations

Cefotaxime sodium (CAS 64485-93-4) is a semisynthetic cephalosporin derivative belonging to the third-generation cephalosporins. Owing to its broad antibacterial activity and its high resistance to beta-lactamases it can be used for a large variety of infections. In the present study the quality standard of 15 different cefotaxime sodium manufacturers from 9 different countries has been examined. The best results were received for the preparation Claforan. None of the 14 other products showed comparable results especially with respect to particulate matter and by-products. The particulate contamination of the 14 foreign products showed relatively high values although they still comply with the limits set by the pharmacopoeias. In contrast, in Claforan very few particles were found in the solution. This is of importance as the drug has to be administered either i.v. as an infusion or i.m. as an injection. Also the amount of by-products measured in the 14 foreign preparations was about 1.5 times higher than the one measured for Claforan. Although these are not critical results, they do indicate that there are marked differences between the quality of the products from different countries which should be taken into account.