Antibiotic Potency Assays
Antibiotic potency tests are a critical component of pharmaceutical quality control that should verify the concentration and bioactivity of active pharmaceutical ingredients (APIs) in antimicrobial drugs. At Chromak Research, we specialize in offering accurate and reliable potency tests measuring the inhibitory strength of antibiotics to microbial growth, ensuring your product passes through regulatory requirements and delivers therapeutic response.
Why Antibiotic Potency Testing Matters
The United States Food and Drug Administration (FDA) requires that all antibiotic products be potency tested before they are released. FDA guidelines and the United States Pharmacopeia (USP <81>) require that potency testing is crucial to ensure that the API content indicated on the product label is the same as the actual biological activity of the final product.
Insufficient assurance of correct potency can result in subtherapeutic dosing or product recalls, jeopardizing not only patient safety but also the reputation of a manufacturer. It is for these reasons that drug manufacturers rely on experienced contract labs like Chromak Research with precise, validated antibiotic potency assays.
Antibiotic Potency Assays USP <81>
At Chromak Research, antibiotic potency assays follow the tough rules in USP. We work under cGMP, so trained staff use approved methods and strict controls to deliver accurate, repeatable results every time.
Cylinder-Plate Assay (Agar Diffusion Method)
This procedure measures inhibition zones resulting from diffusion of antibiotics into agar inoculated with a test microorganism. The diameter of inhibition is directly related to the antibiotic concentration and activity. It is a common bioassay for most antibiotics and provides conformity with USP requirements.
Turbidimetric Assay (Tube Assay Method)
This quantitative technique tests the inhibition of bacterial growth in a liquid culture medium. How cloudy a broth gets-higher turbidity-shows how germs respond when we mix in different doses of an antibiotic. Turbidimetric tests work best when the drug either stops growth quickly or wipes out bacteria entirely.
Laboratories run both techniques with strict controls and trusted benchmarks, so the findings are consistent and reliable.
Our laboratory has strict quality control processes in place, so customers receive potency data they can rely on for product release, stability testing, and regulatory filings.
Applications of Antibiotic Potency Assay
Our antibiotic potency tests find numerous applications across the pharmaceuticals and biotech industries:
Finished product release testing
API batch testing
Stability testing
Method development and validation
Regulatory compliance testing (FDA, EMA, ICH)
We assist injectable producers, oral antibiotics, topical formulations, and others by providing value-added test protocols as per product details.
Join hands with Chromak Research
Chromak Research is the contract-testing lab you lean on when clear results matter most. Our antibiotic-potency tests keep you in line with rules, prove quality, and protect those shelf dates. With quick turnarounds, service shaped around your needs, and state-of-the-art equipment, we are the dependable partner you deserve.