One Partner. Multiple Potency Assay Capabilities.

Precision is everything when determining the potency of antibiotics. Antimicrobial activity must be defined by assessing the concentration of the agent needed to control microorganisms. For this you need a partner who can conduct antibiotic assays with multiple techniques. Sometimes it requires physico-chemical methods, and other times it involves microbiological assays of antibiotics to be carried out — depending on the product and the regulatory requirements. If your product consists of several antibiotics together, a lab that can manage the complexity of this assay is vital. It’s essential to have quality experts that you can rely on to oversee the statistical interpretation of results.

With over 15 years of experience in this specialist field, the Eurofins BioPharma Product Testing network of laboratories supports clients with tailored testing strategies designed to meet global pharmacopeial standards. We offer end-to-end antibiotics potency assay services, delivering both the scientific excellence and regulatory rigour pharmaceutical manufacturers depend on. Our work is conducted in GMP-compliant environments, and our teams are well-versed in statistical data processing, ensuring accurate interpretation and reporting, so you can move forward with confidence. 

Depending on the product and the Pharmacopoeia, different types of analysis are required to titrate antibiotics. Our laboratories perform both physico-chemical (HPLC - pulsed amperometry) and microbiological titration methods to meet regulatory requirements and cover all needs. The methods are carried out throughout the production chain, from the raw material to the finished product, with the aim of verifying the efficacy of the antibiotic across the product life cycle. We are equipped to manage all types of antibiotics, regardless of their formulation, from oral forms such as tablets, capsules, powders, and syrups, to topical applications including ointments, eye drops, and intramuscular or intravenous injections, as well as complex formulations containing multiple antibiotics. 

Our techniques for microbiological titration of antibiotics include: 

  • Diffusion in wells, cylinders and paper discs in accordance with European Pharmacopoeia Chapter 2.7.2
  • Diffusion in cylinders in accordance with USP <81>
  • Turbidimetry in accordance with European Pharmacopoeia <2.7.2> and USP <81> 

Services available

Whether you require a full monograph service (PE, USP & Chinese) or only partial analysis, we can support routine quality control testing for:

Routine QC assays (chapters <2. 7.2> & <81>) 

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  • Raw materials
  • Finished products
  • Residual antibiotics

Method development and validation (ICH Q2)

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  • Matrix effect
  • Linearity
  • Accuracy
  • Fidelity (repeatability & intermediate fidelity)
  • Robustness

Content uniformity (chapter 2.9.40)