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Method Development & Validation

Impact Analytical partners with our customers to develop methods that meet the customer’s validation needs.  Whether you are bringing new products to market, looking for impurities in existing products, or leachable compounds in a drug product, the skills of the Impact Analytical team join forces with our customer’s experts to become an extension of your own in-house team.

Count on Impact Analytical to provide extensive assistance in the development and validation of analytical methods.

Analytical Method Development and Validation

    It is critical in the development of new methods that the analytes of interest be clearly identifiable prior to performing a validation study. The new methodology must be capable of not only observing the analytes in question, but that they are quantifiable, and not obstructed by other components in the matrix.  The Study Directors at Impact Analytical work with our customers to determine the best technique for analysis (given a full understanding of the manufacturing process, the matrix,  and what could potentially be present). Our extensive knowledge in this field helps us to design a testing protocol that will be scientifically defensible when our clients submit their product for approval to the regulatory agencies. The laboratory will develop methods capable of detecting these analytes using the most appropriate sample preparation and analysis techniques. When a suitable method has been defined, a protocol will be provided and the method evaluated in compliance with ICH guidelines.

      Each new method developed by Impact Analytical on behalf of our customers will assess the following:
      • Linearity
      • Precision (repeatability and intermediate precision)
      • Accuracy
      • Specificity
      • Limit of detection
      • Limit of quantification
      • Range
      • Robustness and stability of test solutions

       Advanced analytical techniques and state-of–the-art equipment are employed to perform the analysis required:

      Case Studies

      Industry: Medical Device
      Residual Solvents per USP method <467>
      Modified (467> – read full case study 

      Industry: Consumer Products & Plastics
      Consumer product supplier needed to determine if Bisphenol-A (BPA) was present in their final products: polymer containers, lids, and storage bags.
      : BPA Testing – read full case study

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