Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin®

P. A. Lambert, B. R. Conway

Research output: Contribution to journalArticle

31 Citations (Scopus)

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).

LanguageEnglish
Pages357-368
Number of pages12
JournalJournal of Chemotherapy
Volume15
Issue number4
Publication statusPublished - 1 Aug 2003
Externally publishedYes

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Generic Drugs
Ceftriaxone
Pharmaceutical Preparations
Pharmacopoeias
Infertility

Cite this

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Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin®. / Lambert, P. A.; Conway, B. R.

In: Journal of Chemotherapy, Vol. 15, No. 4, 01.08.2003, p. 357-368.

Research output: Contribution to journalArticle

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