We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration ...
Background: Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and innovator products (pharmaceutical equivalence) is a basic requirement of ...
Dr Martin Cockcroft, Operations Manager at Tepnel Pharmaceutical Services, an established business of Gen-Probe Inc., speaks about harmonized microbiology methods. Dr Martin Cockcroft, Operations ...
The Journal of Microbiological Methods publishes original articles, notes and review articles on novel and/or state-of-the-art methods as well as significant improvements to existing methods.
Dublin, April 20, 2023 (GLOBE NEWSWIRE) -- The "Microbiological Rapid Method Sterility Testing (RMT) of Short Dated and Other Products" webinar has been added to ResearchAndMarkets.com's offering. USP ...
The HPLC analysis of amphotericin B reported in the literature used either a weak acid or the chelating agent EDTA in the mobile phase. The weak acid improves the chromatographic peak shape by ...
The ISO 16140-1:2016 standard for the validation of alternative (proprietary) microbiological methods provides a specific protocol and guidelines. Jun 24, 2016 ISO announced that the ISO 16140:2003 ...
A total of 6432 cell cultures was assayed for mycoplasmas over a 6-year period by aerobic and anaerobic incubation of agar and broth media. Mycoplasmas were detected in 375 cultures (5.8%). M. orale ...
ASTM has worked diligently to develop a microbial barrier test for terminally sterilized packaging. In 1997, the European Committee for Standardization (CEN) and International Organization for ...
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