Method Development

  • What is Method Development?

    According to FDA Guidance method development is an activity designed to create an analytical procedure “to test a defined characteristic of the drug substance or drug product against established acceptance criteria for that characteristic.” While method development may be performed for non-regulatory purposes it can be very important to develop a method with an eye towards validating it in the future. This can save time and resources in future validation activities. The FDA identified the following parameters that may be included in a method development study including: specificity, linearity, limits of detection (LOD) and limits of quantitation (LOQ), range, accuracy, and precision.

  • EKG Labs Method Development
Method Development Services at EKG Labs

Method development is the cornerstone for medical device and pharmaceutical development. It is often one of the first steps in identifying and understanding the chemical nature of a target molecule or material. It can also be used to identify potential impurities in a formulation as well as potential degradants. At EKG Labs we provide method development services for a wide range of analytical techniques and materials.

Analytical Techniques
  • Chromatography – HPLC, LC/MS, GC, GC/MS, GC/FID, GC/TCD, GPC, 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 Expertise
  • Drug Substance/API
  • Drug Product
  • Impurities
  • Degradants
  • Polymers, Plastics, Resins and Coatings
  • Metals and Alloys
  • Ceramics and Composites
  • Novel Materials