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Case Study: Stability Sample Testing Support under cGMP

PROBLEM: Stability Sample Testing Support under cGMP

SOLUTION: Developed and Validated a Method under cGMP for Continuous Testing of the Client’s Product.


A pharmaceutical company was in need of stability sample analysis support for related substances (impurities).  A method was supplied for development and validation to Impact Analytical. Ongoing (monthly) testing of release batches was needed, with turnaround in 3-5 days.

Impact Analytical developed and validated a method for impurities using HPLC with a photodiode array (PDA) detector, under cGMP.
 The method was accurate, precise, repeatable, and robust for ongoing batch release testing under cGMP.  The method involved simple sample preparation conditions and short (<15 minute) HPLC run times to allow for quick turnaround of future samples.  Ongoing batch release testing support was provided by Impact Analytical with delivery of results within 3-5 days.  Testing was done with strict adherence to FDA guidelines for cGMP, at a price that met the client’s budget.  

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