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 with accuracy. The verification focuses on:
- Multiple injections of the reference standard for calculation of %CV
- Verification of retention time of the standard and the sample
- Review of blank (diluent) chromatogram with analyte of interest and
- Overall review of the chromatogram for peak shape
ARL applies good chromatographic practices, good documentation practices and utilizes a USP grade reference standard.
ARL also offers validation services. If you would like to validate a formulation specific potency method for your product(s) please contact us info@arlok.com.
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