USP 51 with suitability

USP 51 with suitability preservative effectiveness testing to assess antimicrobial effectiveness at standard evaluation timepoints including Day 14 and Day 28.

Price per sample:

$500

Additional information

Turnaround Time

6 weeks

Sample Size

250mL

Quantity

Preservative Effectiveness Testing (USP <51> with Suitability)

Our Preservative Effectiveness Testing (PET) service evaluates the ability of a formulation to inhibit microbial growth throughout its intended shelf life. We perform testing in accordance with USP <51> Antimicrobial Effectiveness Testing, including method suitability, to confirm that the test system accurately measures preservative performance.

Preservative effectiveness testing is a critical requirement for cosmetic, pharmaceutical, and personal care products that rely on antimicrobial systems for product safety. Therefore, USP 51 testing supports both regulatory compliance and product quality assurance.

What Is USP <51> with Suitability?

USP <51> defines standardized challenge testing procedures used to assess whether a product’s preservative system effectively controls microbial growth over time. Method suitability is performed to demonstrate that the product matrix does not interfere with microbial recovery or enumeration. As a result, suitability testing ensures that PET results are reliable and scientifically valid.

The test method is published by the United States Pharmacopeia and is widely accepted by regulators and quality organizations.

Standard Timepoints and Evaluation

Preservative effectiveness testing typically includes microbial enumeration at defined intervals. Standard evaluation timepoints include:

  • Day 14 (D14)

  • Day 28 (D28)

Additional interim or extended timepoints may be included based on product type or regulatory requirements.

What Our Preservative Effectiveness Testing Includes

Our PET service includes:

  • Method suitability assessment

  • Inoculation with standard challenge microorganisms

  • Controlled incubation and sampling

  • Microbial enumeration at defined timepoints

  • Evaluation against USP <51> acceptance criteria

  • Clear and defensible reporting

In addition, we review results for consistency and regulatory alignment prior to report issuance.

Products Commonly Tested

Preservative effectiveness testing is commonly performed on:

  • Cosmetic and personal care products

  • Topical pharmaceutical products

  • Creams, lotions, gels, and liquids

  • Products with water-based or high-risk formulations

Because preservative performance directly affects product safety, routine PET supports both development and ongoing quality programs.

Why Choose Pentyl Labs?

Pentyl Labs delivers clear and defensible USP 51 with suitability testing with practical turnaround times. Moreover, we support broader microbiological services, including microbial limits testing and time-kill studies. As a result, PET data integrates smoothly into regulatory submissions and product safety programs.

📩 Contact [email protected] to request Preservative Effectiveness Testing (PET).

Description

Preservative Effectiveness Testing (USP <51> with Suitability)

Our Preservative Effectiveness Testing (PET) service evaluates the ability of a formulation to inhibit microbial growth throughout its intended shelf life. We perform testing in accordance with USP <51> Antimicrobial Effectiveness Testing, including method suitability, to confirm that the test system accurately measures preservative performance.

Preservative effectiveness testing is a critical requirement for cosmetic, pharmaceutical, and personal care products that rely on antimicrobial systems for product safety. Therefore, USP 51 testing supports both regulatory compliance and product quality assurance.

What Is USP <51> with Suitability?

USP <51> defines standardized challenge testing procedures used to assess whether a product’s preservative system effectively controls microbial growth over time. Method suitability is performed to demonstrate that the product matrix does not interfere with microbial recovery or enumeration. As a result, suitability testing ensures that PET results are reliable and scientifically valid.

The test method is published by the United States Pharmacopeia and is widely accepted by regulators and quality organizations.

Standard Timepoints and Evaluation

Preservative effectiveness testing typically includes microbial enumeration at defined intervals. Standard evaluation timepoints include:

Additional interim or extended timepoints may be included based on product type or regulatory requirements.

What Our Preservative Effectiveness Testing Includes

Our PET service includes:

In addition, we review results for consistency and regulatory alignment prior to report issuance.

Products Commonly Tested

Preservative effectiveness testing is commonly performed on:

Because preservative performance directly affects product safety, routine PET supports both development and ongoing quality programs.

Why Choose Pentyl Labs?

Pentyl Labs delivers clear and defensible USP 51 with suitability testing with practical turnaround times. Moreover, we support broader microbiological services, including microbial limits testing and time-kill studies. As a result, PET data integrates smoothly into regulatory submissions and product safety programs.

📩 Contact [email protected] to request Preservative Effectiveness Testing (PET).