Significance of Reconstitution Time and Other Physical Parameters for Evaluation of Dry Powder Injectables

Pai, Girish K and Vamshi, Krishna T and Lewis, Shaila and Ushasree, M (2013) Significance of Reconstitution Time and Other Physical Parameters for Evaluation of Dry Powder Injectables. International Journal of Pharmacy Sciences, 5 (3). pp. 612-614. ISSN 0975-1491

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Abstract

Objective: The objective of the study was to compare marketed Generic and Innovator product of Meropenem for injectionnearing theshelf life. Method: The marketed samples of Generic and Innovator Company were tested for pH, Clarity, Appearance of the product and Reconstitution time. All the samples were reconstituted and pH was determined using calibrated pH meter. Results: No phenomenal differences in Innovator and Generic samples were observed with respect to pH and clarity,whereas phenomenal differences were seen in reconstitution time and appearance of the product. Innovator product showed fast and good reconstitution time, clarity and appearance complying with referenced pharmacopoeias. Conclusion: The increase in reconstitution time of generic product may be due to sourcing of raw material from less regulated markets (economic source) or a different method of manufacturing employed by raw material manufacturer.

Item Type: Article
Uncontrolled Keywords: Meropenem; Reconstitution time; Clarity and Appearance of the product.
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutics
Depositing User: KMC Manipal
Date Deposited: 21 Oct 2013 04:43
Last Modified: 21 Oct 2013 11:07
URI: http://eprints.manipal.edu/id/eprint/137527

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