Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin (R)

Peter A. Lambert, Barbara R. Conway

Research output: Contribution to journalArticlepeer-review

Abstract

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).
Original languageEnglish
Pages (from-to)357-368
Number of pages12
JournalJournal of Chemotherapy
Volume15
Issue number4
Publication statusPublished - Aug 2003

Keywords

  • ceftriaxone
  • Rocephin (R)
  • generics
  • pharmaceutical quality

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