Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia

Abstract

Objectives: To compare the pharmaceutical quality of original and generic ceftriaxone sodium preparations for injection produced in Eastern Asia.

Methods: Standard 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.

Results: Eight 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.

Conclusions: All 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.

• Ceftriaxone
• Rocephin
• Pharmaceutical quality
• Generics
• Eastern Asia