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.” Additionally, even in cases where method development may be performed for non-regulatory purposes, it can be very important to develop a method with an eye toward validating it in the future. This can save significant time and resources in future validation activities. The FDA recommends the inclusion of the following parameters in a method development study: specificity, linearity, limits of detection and quantitation (LOD and LOQ), range, accuracy, and precision.
Method Development Services at EKG Labs
Method development is the cornerstone of 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 or degradants in a formulation. At EKG Labs we develop methods for a wide range of analytical techniques and materials, though we specialize in extractable/leachable methods and impurity methods. We also provide method validation services for methods developed both in-house and externally.
- 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
- Drug Substance/API
- Drug Product
- Polymers, Plastics, Resins, and Coatings
- Metals and Alloys
- Ceramics and Composites
- Novel Materials