Active Pharmaceutical Ingredient and Finished Product
ICH Q2(R1) is considered the primary reference for recommendations and definitions on validation characteristics for analytical procedures.
Tepnel’s GMP laboratories based in Livingston, Scotland have provided over 30 years of quality control analytical testing in support of active pharmaceutical ingredients (API), in-process testing and finished products on a wide variety of dosage forms of small molecules for all phases of the drug development process.
Utilising Waters HPLC, UPLC and the Waters H-Class HPLC method development platform, we adopt a flexible and customisable approach to developing and validation of methods that are fit for purpose across the spectrum of available detection technologies. Our scientists have developed and validated methodology for active ingredient quantitation, related substances quantitation, stability indicating, dissolution applications including other routine quality control applications and across a range of separation and quantitation technologies.
Our method development experience includes:
- Optimising enzymatic digestion to create a stable derivative enabled us to develop a LC/MS/MS method to measure concentrations of a key biomarker directly related to the activity of a biologic.
- The development of a novel extraction and derivatisation scheme allowed us to simultaneously determine free and covalently bound drug concentrations using a single assay.
- The development of a non-traditional internal standard by derivatisation allowed our client to maintain their rigorous timeline without resorting to an expensive synthetic effort.
- Employing selective extraction in method development enabled the accurate determination of in vivo drug concentration in plasma samples collected during our client’s Phase I trial.
- Increasing assay sensitivity to determine drug concentration in epithelial lining fluid (ELF) samples allowed our client’s clinical trial to proceed uninterrupted, saving them time and resources.
