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Pharmaceutical quality of ceftriaxone generic drug products compared with rocephin

Lambert, P.A. and Conway, Barbara R (2003) Pharmaceutical quality of ceftriaxone generic drug products compared with rocephin. Journal of Chemotherapy, 15 (4). pp. 402-413. ISSN 1120-009X

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The pharmaceutical qualities of 34 ceftriaxone generic products were compared with Rocephin® as the reference standard. Quality standards specified in the European and US Pharmacopoeias were violated on 18 occasions, including those for sterility (4 products) and impurities (5 products). All 34 generics tested failed to meet Roche specifications for Rocephin®, with 100 contraventions of the Roche Pharmaceutical standards. The most common failures amongst generic drug products were clarity of solution (30 products) and presence of thiotriazinone (33 products).

Item Type: Article
Subjects: Q Science > Q Science (General)
Q Science > QD Chemistry
Schools: School of Applied Sciences
School of Human and Health Sciences > Institute for Skin Integrity and Infection Prevention
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Depositing User: Sharon Beastall
Date Deposited: 05 Nov 2010 09:04
Last Modified: 28 Aug 2021 11:01


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