Comparative Evaluation of Cephalosporin Injectable Product Manufactured by Generic and Innovator Company

The main purpose of the study was to compare few physical parameters of the marketed products of Ceftriaxone Sodium for injection 1g manufactured by generic and innovator company nearing the expiry date. The marketed samples of generic and innovator company were tested for physical parameters like Appearance, pH, clarity, reconstitution time and primary packing quality. All the samples were reconstituted and pH was determined using calibrated pH meter. From the results it was found that few physical parameters were comparable in innovator and generic samples with respect to parameters like pH and clarity whereas phenomenal difference was observed in reconstitution time and appearance of the product. Innovator product showed very less reconstitution time, good clarity of reconstituted solution and acceptable physical appearance or description. The increase in reconstitution time & inferior physical appearance observations of generic product may be because of sourcing of raw materials from less regulated countries (economic source) or depends on other important processing parameters like method of manufacturing (different process employed by innovator and generic company), in-process controls, quality of starting materials or even quality of intermediates used for manufacturing of raw materials that is being sourced by the generic company.