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USP <61> and <62> Pharmaceutical Product for Bioburden

$420.00

PHPT- 039, <61>/<62>  Bioburden Quantitative Proficiency Test (PT) for Specified Microorganisms in Non-Sterile Products by USP <61> or equivalent. Samples... read more

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Catalog Number:
PHPT-039
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Product Details

Product Details

PHPT- 039, <61>/<62>  Bioburden

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.

Qualitative Proficiency Test (PT) for Specified Microorganisms in Non-Sterile Products by USP <62> or equivalent. Samples are provided as a panel of five single-pellet vials plus five 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 may report qualitative results of either present or absent for their samples. Three of the five samples will contain microorganisms and therefore be positive. Participants are asked to identify a positive sample by indicating present and identify a negative sample by indicating absent.

The positive microorganism may be any of the following species Staphylococcus aureus, Bacillus subtilis,  Pseudomonas aeruginosa, Candida albicans, or Aspergillus brasiliensis, Salmonella enterica Typhi, Escherichia coli and Salmonella enterica Abony.

A negative sample will be sterile and not contain any microorganisms.

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

 

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