Compendial Testing

Perritt Laboratories performs microbiological method qualification and testing according to methods listed in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur. or EP) and Japanese Pharmacopoeia (JP). In addition, we perform testing according to AOAC Official Methods of Analysis, ASTM testing standards, AAMI and other standard testing compendia.

Whether testing to meet United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur. or EP), Japanese Pharmacopoeia (JP) or other compendial requirements, our full-service, cGMP, ISO 17025 accredited microbiological testing services can provide you with timely test results that you require, backed by a staff of dedicated professionals that have been at the forefront of testing since 1973.

Perritt Laboratories provides decades of experience and expertise in microbiological testing with a world-class quality system to back it all up. You can trust our data…..companies the world over have for over 40 years.

Microbiological Compendial Testing

 

Our microbiology compendia testing services include:

·         Harmonized Microbial Content (Microbiological Examination Of Non-sterile Products/Microbial Limits)

    • United States Pharmacopeia (USP)  <61>,  Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests and USP <62>, Microbiological Examination of Non-sterile Products: Tests for Specified Microorganisms

    • European Pharmacopeia (Ph. Eur. or EP) <2.6.12>, European Pharmacopeia (Ph. Eur. or EP)  <2.6.13>

    • Japanese Pharmacopoeia (JP) <35>, Microbial Limit Test

·         Antimicrobial/Preservative Effectiveness Testing

    • United States Pharmacopeia (USP) <51> Antimicrobial Effectiveness Testing

    • European Pharmacopeia (Ph. Eur. or EP) 5.1.3 Efficacy of Antimicrobial Preservation

    • Japanese Pharmacopeia (JP) 19, Preservative Effectiveness Tests

·         Endotoxin Testing (gel clot, kinetic/turbidimetric)

    • United States Pharmacopeia (USP) <85> Bacterial Endotoxins Test

    • European Pharmacopeia (Ph. Eur. or EP) <2.6.14> Bacterial Endotoxins

    • Japanese Pharmacopoeia (JP) <4.01> Bacterial Endotoxins Test

·         Water Systems

    • United States Pharmacopeia (USP) and European Pharmacopeia (Ph. Eur. or EP) Water Monograph Testing

    • United States Pharmacopeia (USP)  <1231> Water for Pharmaceutical Purposes

·         Disinfection Efficacy

o    ASTM, AOAC

  • Method Development and Validation according to USP <1227>, Validation of Microbial Recovery from Pharmacopeial Articles

You may find larger laboratories, but you won’t find a testing lab that can match our recognized expertise and personal touch. We know our clients by name, not client number, and it shows in their satisfaction with our testing services.