- Testing Types
- Antimicrobial Potency Assay (USP <81>)
Terms and Conditions
Sample Submission Form
Overview
Antimicrobial potency refers to the biological activity of an antimicrobial or antibiotic product and its ability to inhibit the growth of specific microorganisms. At PLS Analytical, potency assessments help manufacturers verify that products consistently deliver the intended therapeutic performance throughout development and commercial production.
PLS Analytical performs antimicrobial potency assays in accordance with USP <81> to compare the activity of test samples against qualified reference standards. These studies evaluate antibiotic effectiveness of the finished products, and stability samples, generating reliable data to support quality programs and regulatory requirements.
The effectiveness of antimicrobial products depends on maintaining consistent biological activity throughout manufacturing, storage, and shelf life. Potency testing helps manufacturers verify product performance, support batch release decisions, and demonstrate compliance with pharmacopeial and regulatory expectations.
PLS Analytical delivers scientifically robust USP <81> potency testing that generates reliable, regulatory-ready data for quality systems, stability programs, and commercial manufacturing.
Testing Services
PLS Analytical performs antimicrobial potency testing in accordance with USP <81> requirements using established microbiological assay techniques designed to evaluate biological activity and product effectiveness.
Cylinder Plate Method
Cylinder Plate Method
The Cylinder Plate Method evaluates antimicrobial potency by measuring zones of microbial growth inhibition around a test sample. Scientifically robust data supports antibiotic drug products, raw materials, APIs, routine potency testing, and USP <81> compliance.
Finished Product Potency Testing
Finished Product Potency Testing
Finished product potency testing evaluates the biological activity of antimicrobial products to verify compliance with product specifications and release requirements. Scientifically robust data supports commercial products, batch release programs, quality control,, and regulatory compliance.
Stability Potency Studies
Stability Potency Studies
Stability potency studies evaluate changes in antimicrobial activity throughout defined storage conditions and shelf life. Scientifically robust data supports stability programs, shelf-life evaluations, lifecycle management, and regulatory submissions.
Method Validation & Suitability
Method Validation & Suitability
Method validation and suitability evaluate the performance of antimicrobial potency assays to demonstrate accuracy, precision, and reliability for specific product matrices. Scientifically robust data supports new product development, method implementation, quality programs, and regulatory compliance.
Advantages
Antimicrobial potency testing supports product quality, regulatory compliance, and manufacturing confidence by verifying that antimicrobial products maintain their intended biological activity.
Biological Activity Verification
Confirms that antimicrobial and antibiotic products retain the activity required to inhibit target microorganisms effectively.
Reliable Potency Data
Testing performed using validated microbiological methods to generate accurate, reproducible, and defensible potency results.
Stability & Lifecycle Support
Supports release testing, stability programs, product development activities, and ongoing quality monitoring throughout the product lifecycle.
