Potency, Purity, Stability indicating

Compliance with ICH Q7, requires that analytical methods should be validated to reflect the purpose of the analysis and the stage of the API or finished product production process. In relation to GMP, analytical methods generally fall into three discrete types, identification, limit tests or quantitative assays.

Active and related
substances assays

At Tepnel, we specialise in the development and validation of quantitative methods for active/potency assessments, related substances/purity and stability indicating. We have provided method development for a wide range or formulation types and active ingredients.

The key to developing a successful assay lies in the selectivity and specificity of the technique deployed. Liquid chromatography remains the most popular approach for developing and validating quantitative, stability indicating assays for small molecule and related substances. At Tepnel, we deploy a range of different detection technologies which coupled with the right stationary phase, mobile phase, wavelength and pH facilitates the optimum performance for quantitative analysis.

Detection technologies coupled to Waters ACQUITY UPLC H-Class System available at Tepnel include:

  • UV
  • PDA
  • Fluorescence
  • ELSD
  • MALS
  • RI
  • TUV
  • SQD
  • CAD
  • MS

Potency and purity assays

In terms of biologics, potency is the measure of the specific ability or capacity of an active ingredient or finished product to affect the requisite response or effect. To quantitatively measure this, Tepnel can develop and validate assays that would be either a bioassay, surrogate assay or matrix approach.

At Tepnel, we are aware of the challenges in developing assays that can be fit for their intended purpose. With over 20 years of experience our scientists are there to help design and execute development programs which address challenges such as, limited material availability, timelines from harvest to test result, the inherent issues of lot to lot variability, complex mechanisms of action and limited availability of reference standards.

Potency assays developed and validated at Tepnel can be used in any of the following endpoint applications:

  • Biological activity of active
  • Activity of related substances
  • Quantitative analysis for lot release or product stability

You may also be interested in:

ICH Method Development 
and Validation

API and Finished Products

Large Molecule Formulations