The antimicrobial effectiveness test (previously known as the preservative effectiveness test),is a compendial test (antimicrobial test is described in USP <51>) performed during formulation development and stability testing of sterile parenteral multi-dose presentations of drug products that contain a preservative system.This test is intended to reproducible biological measurement of the activity of the preservative system in a product.
The
compendial AET tests of the USP and the European Pharmacopeia have very similar
methods, but they differ in sampling points and acceptance criteria.
How many batches shall be subjected for AET testing during stability
study?
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1.According to “USFDA Guidance for industry ANDAs: Stability Testing
of Drug Substances and Products - Questions and Answers”
"One of
the primary batches of the drug product should be tested for antimicrobial
preservative effectiveness (in addition to preservative content) at the end
of the proposed shelf life. The drug product specification should include a
test for preservative content, and this attribute should be tested in all
stability studies".
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