| Literature DB >> 21221871 |
Cheryl L Moser1, Brian K Meyer.
Abstract
The antimicrobial effectiveness or preservative effectiveness test is described in the tripartite compendia for sterile parenteral multi-dose formulated products. The execution of the test is essentially harmonized with respect to inoculum preparation and test execution but not the acceptance criteria. This article describes how a single test can be performed that procedurally satisfies all of the compendia and their acceptance criteria.Mesh:
Substances:
Year: 2011 PMID: 21221871 PMCID: PMC3066379 DOI: 10.1208/s12249-010-9575-9
Source DB: PubMed Journal: AAPS PharmSciTech ISSN: 1530-9932 Impact factor: 3.246