Method Development and Validation

We provide the resources and flexibility to develop and improve analytical methods tailored to your specific needs. Our laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer — covering procedures for active pharmaceutical ingredients, drug formulations, cosmetics, personal care products and raw materials.

Our scientists work under strict compliance with cGMP requirements and base our operations on detailed SOPs and stringent quality assurance practices. We provide effective and efficient communication through the duration of your project. You’ll receive a comprehensive report that details the procedures, analytical method, protocols, all test results, graphs and calculations and sample raw data (e.g., GC/HPLC chromatograms).

Our analytical techniques measure accuracy, precision, specificity, limit of detection/limit of quantitation (LOD/LOQ), linearity, range and robustness:

• HPLC: UV variable wavelength, refractive index (RI), photo diode array detectors
• GC: Flame ionization detector (FID), thermal conductivity detector (TCD), direct injection and headspace analysis
• GC/MS: Identification of chemical structure and molecular weight determination based on the library of compounds
• Atomic absorption spectrophotometry (flame)
• UV/visible spectroscopy
• ICP-MS

We also have the capabilities to develop and validate a wide variety of other analytical methods for small molecules and biologics in either a liquid or solid state. Identification tests, limit tests, assays and quantitative analyses are four methods required for various stages of drug development. We develop these methods using analytical techniques such as LC, MS, NMR, XRPD, IR, Raman, thermal analysis, vapor sorption, particle size and microscopy.

Phase-appropriate method development is always a consideration to ensure that the necessary characteristics are evaluated for each method. We develop and validate all methods according to International Conference on Harmonisation (e.g., ICH Q2(R1), Q2B, and Q6A) and FDA guidelines.

Our chemometricians design experimentation for complex methods requiring principal component analysis or partial least squares regression. We also have significant experience with detecting and quantifying minor amounts of amorphous or crystalline forms in both drug substances and drug products. Our experts have successfully transferred many types of methods into our laboratory, and we can also transfer developed methods to your production site.