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Microbiological assay of two selected products of ceftriaxone powder for injection from pharmaceuticals' market in Sudan
Joint Authors
Source
Sudan Journal of Medical Sciences
Issue
Vol. 9, Issue 4 (31 Dec. 2014), pp.251-257, 7 p.
Publisher
Omdurman Islamic University Faculty of Medicine
Publication Date
2014-12-31
Country of Publication
Sudan
No. of Pages
7
Main Subjects
Topics
Abstract EN
Background : Different techniques have classically been used to evaluate and assure the quality of medicines circulated on the market; one of the commonly uses is chemical analysis.
However, some evidence has shown that there are other important indicators (e.g.
bioequivalence, relative potency, etc.) that should also be considered when evaluating the quality of pharmaceutical products.
Materials and Methods : A microbiological assay was conducted to compare the relative potency of two Ceftriaxone products (with a third one used as standard product) from the market using 3 reference bacteria including Streptococcus pneumoniae, Klebsiella pneumoniae and Staphylococcus aureus.
Serial dilutions were made with the corresponding 1, 4, 8, 16 and 32-fold Minimum Inhibitory Concentration (MIC) of Ceftriaxone against the bacteria under investigation.
Results : The relative potency of one product compared to the standard product was estimated to be within the acceptable range of bioequivalence (89.6 %), while the other product showed unacceptable relative potency (72.3 %).
Conclusions : The microbiological assay is an effective and simple method for comparing the equivalency of injectable products.
A complaint reporting system about quality and effectiveness problems needs to be considered as a priority source of such information to inform decision-makers.
American Psychological Association (APA)
Idris, A. M.& Ibrahim, K. E.. 2014. Microbiological assay of two selected products of ceftriaxone powder for injection from pharmaceuticals' market in Sudan. Sudan Journal of Medical Sciences،Vol. 9, no. 4, pp.251-257.
https://search.emarefa.net/detail/BIM-565756
Modern Language Association (MLA)
Idris, A. M.& Ibrahim, K. E.. Microbiological assay of two selected products of ceftriaxone powder for injection from pharmaceuticals' market in Sudan. Sudan Journal of Medical Sciences Vol. 9, no. 4 (Dec. 2014), pp.251-257.
https://search.emarefa.net/detail/BIM-565756
American Medical Association (AMA)
Idris, A. M.& Ibrahim, K. E.. Microbiological assay of two selected products of ceftriaxone powder for injection from pharmaceuticals' market in Sudan. Sudan Journal of Medical Sciences. 2014. Vol. 9, no. 4, pp.251-257.
https://search.emarefa.net/detail/BIM-565756
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references : p. 256-257
Record ID
BIM-565756