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More potency assay results for generic non-USA lots of piperacillin/tazobactam and initial reports for generic meropenem compounds marketed in the USA.

Abstract：

:An ongoing program of international generic antimicrobial potency assays for piperacillin/tazobactam has been summarized here through December 2010, and the initial results for meropenem generic lots from the United States are also presented. Fifteen additional piperacillin/tazobactam generic lots revealed an average of -10% activity (range, +3 to -23%) compared to the branded product (Zosyn®; Wyeth-Pfizer), a finding consistent with prior reports (46 lots) of -16%. In contrast, meropenem branded and generic products had equivalent assay results (5 generic lots from 2 manufacturers [Hospira and Sandoz]). In conclusion, potencies for generic lots of parenteral broad-spectrum β-lactams can vary widely when directly compared to branded products, requiring documentation by chemical, in vitro activity (potency assays as measured here), and purity testing before considering their addition to a hospital formulary.

journal_name

Diagn Microbiol Infect Dis

journal_title

Diagnostic microbiology and infectious disease

authors

Jones RN,Sader HS,Flamm RK,Watters AA

doi

10.1016/j.diagmicrobio.2013.01.024

subject

Has Abstract

pub_date

2013-05-01 00:00:00

pages

110-2

issue

1

eissn

0732-8893

issn

1879-0070

pii

S0732-8893(13)00063-1

journal_volume

76

pub_type

杂志文章

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