Method Validation

  • What is Method Validation?

    According to the FDA, “Analytical method validation is the process of demonstrating that an analytical procedure is suitable for its intended purpose. The methodology and objective of the analytical procedures should be clearly defined and understood before initiating validation studies. This understanding is obtained from scientifically-based method development and optimization studies.” In simple terms, this means a validated method is fit for purpose and can consistently account for a wide variety of variables.

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Method Validation at EKG Labs

At EKG Labs we provide method validation services under GMP and GLP conditions to support medical device and pharmaceutical development. We can develop a starting method or use your existing method and then validate according to your needs. Typically, our method validations follow ICH and USP guidelines which include:

  • Specificity
  • Linearity
  • Accuracy
  • Precision (repeatability, intermediate precision, and reproducibility)
  • Range
  • Quantitation limit (LOQ)
  • Detection limit (LOD)
Analytical Techniques
  • Chromatography – HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
  • Spectroscopy – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
  • Other- TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer
Material and Application Expertise
  • Drug Substance/API
  • Drug Product/Drug Formulation
  • Organic Impurities
  • Elemental Impurities
  • Residual Solvents
  • Leachables
  • Degradants
  • Polymers, Plastics, Resins, and Coatings
  • Metals and Alloys
  • Ceramics and Composites
  • Novel Materials