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USP 51 Antimicrobial Effectiveness Test (No Suitability)
USP 51 Challenge Test (No Suitability): Antimicrobial effectiveness testing using five microorganisms with plate evaluations at Day 14 and Day 28. Suitability testing is not included.
Price per sample:
$400
Additional information
| Turnaround Time | 6 weeks |
|---|---|
| Sample Size | 250mL |
USP 51 Antimicrobial Effectiveness Test (No Suitability)
USP 51 Challenge Test evaluates the effectiveness of a preservative system in cosmetic, personal care, and topical products. This antimicrobial effectiveness test measures how well a formulation controls microbial growth over time following intentional inoculation.
This version of the test follows USP <51> Antimicrobial Effectiveness Testing requirements without suitability testing. It is commonly selected when formulation compatibility has already been demonstrated or when clients require confirmation testing only.
During the study, the product is challenged with five standard microorganisms, including bacteria, yeast, and mold. These organisms represent common sources of contamination encountered during manufacturing and consumer use. After inoculation, analysts incubate the samples under controlled conditions.
Microbial recovery is evaluated using plate count methods at Day 14 and Day 28. Analysts compare results against USP acceptance criteria to determine whether the preservative system effectively limits microbial growth throughout the test period. This approach provides clear, measurable evidence of antimicrobial performance.
The USP 51 Challenge Test supports a wide range of applications, including product development, reformulation projects, preservative screening, and quality assurance programs. Manufacturers often use the data to confirm preservative performance prior to market release or during routine compliance reviews.
Because many regions restrict or prohibit animal testing, antimicrobial effectiveness testing using standardized in-vitro microbiological methods has become the accepted industry standard. As a result, USP 51 testing plays a critical role in supporting product safety and regulatory expectations.
This test is frequently performed as part of broader Preservative Efficacy Testing and Microbiological Testing Services programs. Guidance from the United States Pharmacopeia (USP) defines the organisms, procedures, acceptance criteria, and reporting expectations for this method.
Overall, the USP 51 Challenge Test provides reliable data to support preservative system performance, reduce microbial risk, and strengthen product safety documentation.
Description
USP 51 Antimicrobial Effectiveness Test (No Suitability)
USP 51 Challenge Test evaluates the effectiveness of a preservative system in cosmetic, personal care, and topical products. This antimicrobial effectiveness test measures how well a formulation controls microbial growth over time following intentional inoculation.
This version of the test follows USP <51> Antimicrobial Effectiveness Testing requirements without suitability testing. It is commonly selected when formulation compatibility has already been demonstrated or when clients require confirmation testing only.
During the study, the product is challenged with five standard microorganisms, including bacteria, yeast, and mold. These organisms represent common sources of contamination encountered during manufacturing and consumer use. After inoculation, analysts incubate the samples under controlled conditions.
Microbial recovery is evaluated using plate count methods at Day 14 and Day 28. Analysts compare results against USP acceptance criteria to determine whether the preservative system effectively limits microbial growth throughout the test period. This approach provides clear, measurable evidence of antimicrobial performance.
The USP 51 Challenge Test supports a wide range of applications, including product development, reformulation projects, preservative screening, and quality assurance programs. Manufacturers often use the data to confirm preservative performance prior to market release or during routine compliance reviews.
Because many regions restrict or prohibit animal testing, antimicrobial effectiveness testing using standardized in-vitro microbiological methods has become the accepted industry standard. As a result, USP 51 testing plays a critical role in supporting product safety and regulatory expectations.
This test is frequently performed as part of broader Preservative Efficacy Testing and Microbiological Testing Services programs. Guidance from the United States Pharmacopeia (USP) defines the organisms, procedures, acceptance criteria, and reporting expectations for this method.
Overall, the USP 51 Challenge Test provides reliable data to support preservative system performance, reduce microbial risk, and strengthen product safety documentation.
