• Isabelle Arnet, Matthias Altermatt, Yves Roggo, and Gabriel Schnetzler.
• Pharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel , Basel, Switzerland.
• J Chemother. 2015 Jan 1; 27 (6): 337-42.

ObjectivesTo compare the pharmaceutical quality of original and generic ceftriaxone sodium preparations for injection produced in Eastern Asia.MethodsStandard physical and chemical laboratory tests were performed. Participants/material: Ceftriaxone (Rocephin®, Roche, Switzerland) was the reference material. Generics produced in China, India, and Indonesia were sampled in China and Myanmar within their expiration dates.ResultsEight generics obtained from Eastern Asia markets in January 2013 were analysed. All eight generics failed the specifications in three or more tests. Residues of solvents and metals were detected in all generics, four were not particle free, and two were not sterile.ConclusionsAll tested generic ceftriaxone products failed to meet the pharmaceutical quality standards of the branded original. The high levels of impurities and the identified contamination of particles and residues are of clinical concern, as they could impact tolerability and safety in patients in need of an effective parenteral antibiotic.

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