REQUEST A QUOTE
REQUEST A QUOTE
Home»Technology»Other Methods»USP Assays

Compendial Assays for Drug Substance / Drug Product Release

United States Pharmacopeia (USP) compendial assays are vital in drug development, ensuring pharmaceutical products meet rigorous standards for quality, safety, and efficacy. These assays guarantee that manufactured drugs consistently adhere to regulatory benchmarks, ensuring batch-to-batch uniformity and optimal bioavailability.

Avance Biosciences offers a portfolio of compendial assays to help our clients meet regulatory and release requirements for their drug substance and/or drug product. These assays include:

Assay Name

Assay Description

Sample Requirements and TAT

Bioburden1

(USP 61/62)

  • Quantitative enumeration of aerobic bacteria and fungi present in the DS/DP to ensure acceptable limits for microbial contamination.
  • Anaerobic bacteria may also be tested as an option.

Dependent on sample type
Note: For samples which require neutralization of inhibitory activity by membrane filtration, only aerobic testing is performed.

TAT: 1-2 weeks

Sterility1

(USP 71)

  • Confirms the absence of viable microorganisms in sterile DS/DP to meet safety requirement.

Dependent on sample type and testing method required (direct inoculation vs. membrane filtration).

TAT: 2-3 weeks

Rapid Sterility Testing

(USP 1071)

  • Sterility testing based on USP 71 with reduced TAT (approximately 3 days) by contaminant detection via ATP Bioluminescence

No special requirement as long as the sample can be filtered.

TAT: within 7 days (3-5 business days)

Endotoxin1

(USP 85)

  • Detects and quantifies endotoxin in DS/DP to safeguard against pyrogenic reactions in parenteral drugs.

100 µl minimum volume

TAT: 1-2 weeks

pH

(USP 791)

  • Ensures the pH of DS/DP falls within acceptable ranges for stability and efficacy.

100 µl minimum volume

TAT: 1-2 weeks

Osmolality

(USP 785)

  • Evaluates DS/DP for biological compatibility to meet safety and potency requirements (product dependent).

1 ml minimum volume

TAT: 1-2 weeks

Color and Achromicity

(USP 631)

  • Assess visual appearance of DS/DP to meet specified color requirements

Glass vial(s) of DS/DP test sample.

TAT: 1-2 weeks

Visible Particle Evaluation

(USP 790)

  • Sample evaluated for the presence of visible particles in injectable products to ensure safety and quality.

Glass vial(s) of DS/DP test sample.

TAT: 1-2 weeks

1 Based on the nature of the tests, different sample requirements may apply. Some test samples may require suitability evaluation before testing depending on formulation

Have Questions?

We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a quick message with your questions to find out what Avance can do for you.

CONTACT US