| Microsafe Services - Antibiotic Microbial Testing | Data sheet - SDS1702ENEU | |
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The antimicrobial activity test is a complex, time-sensitive set of critical tests designed to determine the level of biological activity possessed by the preservative system of a pharmaceutical product. Adequate preservation should prevent or inhibit the growth of microorganisms that may pose a risk of infection to the user or result in product degradation.1 The activity (potency) of antibiotics may be demonstrated under suitable conditions by their inhibitory effect on microorganisms. A reduction in antimicrobial activity will also reveal subtle changes not demonstrable by chemical methods. Accordingly, microbial or biological assays remain generally the standard for resolving doubt with respect to possible loss of activity.2
1 TGA - Therapeutic Goods Administration. Preservative efficacy in multidose pharmaceutical preparations. (May 1999). Retrieved May 10, 2006, from The Australian Government. Department of Health and Ageing Therapeutic Goods Administration website: http://www.tga.gov.au/docs/html/tganews/news29/lab.htm#preserv
2 USP. USP 29-NF 24. General Chapters: <81> Antibiotics-Microbial Assays. 2006.