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.

Stability of ampicillin, piperacillin, cefotaxime, netilmicin and amikacin in an L-amino acid solution prepared for total parenteral nutrition of newborn infants.

The stability of ampicillin, piperacillin and cefotaxime, alone or in combination with either netilmicin or amikacin, was tested by microbiological methods at 29 degrees C (ampicillin, also at 22 degrees C) in an L-amino acid solution specially prepared for newborn infants. In the case of ampicillin, the mean concentration had dropped to 84% of the initial value after 24 hours. This fall is acceptable. Piperacillin and cefotaxime were stable. Admixture of netilmicin or amikacin did not affect the activity of ampicillin, piperacillin and cefotaxime. The concentrations of netilmicin and amikacin were stable for 24 hours. Combination with ampicillin, piperacillin or cefotaxime did not affect the activity of either aminoglycoside. The antibiotics investigated could therefore be used in our TPN infusion system.