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Pharmaceutical Quality of Ceftriaxone Generic Drug Products Compared with Rocephin ®

2003; Taylor & Francis; Volume: 15; Issue: 4 Linguagem: Inglês

10.1179/joc.2003.15.4.357

1973-9478

Peter A. Lambert, Barbara R. Conway,

Biosimilars and Bioanalytical Methods

AbstractAbstractThe 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).