Client Services > Methods
The U.S. Pharmacopeia describes in General Chapter 51, the assay they recommend for testing preservative efficacy. The USP divides products into four categories:
Category 1 - Injectable, emulsion, otic, sterile nasal and opthalmic products made in aqueous bases
Category 2 – Topically used products made with aqueous bases or vehicles; nonsterile nasal products and emulsions, including those applied to the mucous membranes
Category 3 – Oral products other than antacids, made with aqueous bases or vehicles
Category 4 – Antacids made with an aqueous base
Each category of products is challenged with five microorganisms independently and samples are taken at intervals specified for each category throughout 28 days.
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…