For potency testing with respect to HPLC, IC and/or GC methodologies, ARL verifies by way of system suitability that we are capable of performing the analysis. The verification focuses on:
1. Multiple injections of the reference standard for calculation of %CV
2. Verification of retention time of the standard and the sample
3. Review of blank (diluent) chromatogram with analyte of interest and
4. Overall review of the chromatogram for peak shape
ARL applies good chromatographic practices, good documentation practices and utilizes a USP grade reference standard.
ARL does offer validation services. If you would like to validate a formulation specific potency method for your product(s) please contact us info@arlok.com .