USP Proficiency Testing ProgramUSP PT Schemes

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

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Catalog Number:
PHPT-022
Choose Study Number

PH-0921, PH-0122, PH-0422

Product Details

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.

USP PT Schedule

USP PT Schedule

Study Number Study Open Date Study Close Date
PH-0422 4/18/2022 07/15/2022*

Extended from 6/9/22

PH-0922 9/19/2022 11/18/2022
PH-0123 1/16/2023 3/17/2023
PH-0523 5/15/2023 6/14/2023

MSDS/SDS

MSDS/SDS

USP Harmonized Compendial Methods

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

 

USP <62>

Microbiological Examination of Non-sterile Products: Tests for Specified Microorganisms

 

<2.6.13>

 

JP <35> Microbial Limit Test

 

PHPT-015

 

Test for Specified Microorganisms in Non-sterile Products

 

USP <71>

Sterility Testing

 

<2.6.1>

 

JP <4.06>

 

PHPT-021

 

Sterility Test

 

USP <51>

Antimicrobial Effectiveness Testing

 

<5.1.3>

 

JP <19>

 

PHPT-024

 

Preservative Efficacy Test