EP 5.1.3

EP 5.1.3

The European Pharmacopeia describes in General Text 5.1.3, the assay they recommend for testing preservative efficacy. The EP divides products into three tables:

5.1.3-1 - Parenteral and ophthalmic preparations

5.1.3-2 - Topical preparations

5.1.3-3 - Oral preparations

Each category of products is challenged with four microorganisms independently and samples are taken at intervals specified for each category throughout 28 days.  

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In-Vitro Laboratory

Scientists in our In-Vitro testing labs are well trained on ASTM, AATCC, AOAC, CLSI, and EN standard methods. The efficacy testing services of this laboratory include MIC/MBC, biofilm prevention and removal, time-kill kinetics, clean room disinfectant validation, zone of inhibition and custom efficacy studies for disinfectants, antimicrobials and other products requiring EPA registrations and FDA 510(k) submissions. Studies in…

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