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USP <61> Microbial Enumeration of Non-Sterile Products Proficiency Test




Catalog Number:
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PH-0123, PH-0523

Study Number


USP Harmonized Compendial Methods

United States Pharmacopeia (USP) Ph. Eur, EP JP NSI Catalog Item Harmonized Description
 USP  <61>
Microbiological Examination of Non-sterile Products
<2.6.12> JP <35> Microbial Limit Test PHPT-022 Microbial Enumeration of Non-sterile Products


Product Details

Quantitative Proficiency Test (PT) for Specified Microorganisms in Non-Sterile Products by USP <61> or equivalent. Samples are provided as two single-pellet vials plus two vials of talc powder.  Each vial of talc contains 10 grams per vial.  Participants will follow provided step-by-step instructions to prepare each sample for plating onto suitable microbiological media.  Participants will then quantify the microorganism present in the sample.


The positive microorganism may be any of the following species Staphylococcus aureus, Bacillus subtilis,  Pseudomonas aeruginosa, Candida albicans, or Aspergillus brasiliensis.