Quality Assessment of Original and Generic Formulations of Injectable Cefazolin Sodium Products

Abstract

Very little information is available on the quality of generic products and it has recently been reported that anaphylaxy shock occurred when a generic formulation of an injectable cefazolin sodium product was used in a patient before surgery.This suggests that the generic product contained impurities that caused such an adverse reaction.It is therefore important to determine the constituents of generic products and compare them with those of the original products.
We analyzed the original cefazolin sodium product and 4 generics of it by means of high performance liquid chromatography in order to determine differences in quality between them.Three impurities were found in the original product and 4 in the generic products,respectively.However,the impurity content of all of the generic products was significantly higher than that of the original product and on analyzing synthetic samples of impurities which could possibly be contained in the cefazolin sodium products,the chromatographic peaks of three of them overlapped with the peaks observed in the chromatograms of the original and generic products.
These results suggest that there can be great differences in quality between the original and generic products,and that the impurities might be cefazolin-related substances.We must therefore select generics based on an appraisal of the quality information available for them in order to minimize unexpected adverse reactions and achieve more cost effective and safe therapy.