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

Pai, GK and Vamshi, Krishna T and Kumar, Lalit and Anup, N and Naveen, D and Reddy, SM (2013) Comparative Evaluation of Cephalosporin Injectable Product Manufactured by Generic and Innovator Company. International Journal for Pharmaceutical Research Scholars, 2 (1). pp. 56-60. ISSN 2277-7873

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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.

Item Type: Article
Uncontrolled Keywords: Ceftriaxone sodium, Reconstitution time, Clarity and Appearance of the product.
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutics
Depositing User: KMC Manipal
Date Deposited: 28 Mar 2013 11:05
Last Modified: 21 Oct 2013 11:12

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