We have the capabilities to develop and validate a wide variety of analytical methods for small molecules and biologics in either the liquid or solid state. Identification test, limit tests, assays, and quantitative analyses are four of the most often required methods for various stages of drug development. Some of the common analytical techniques used for developing these methods include: LC, MS, NMR, XRPD, IR, Raman, thermal analysis, vapor sorption, particle size, microscopy, and others. Phase appropriate method development is always a consideration to ensure that the necessary characteristics are evaluated for each method. All methods can be developed and validated according to International Conference on Harmonisation (e.g., ICH Q2(R1), Q2B, and Q6A) and FDA guidelines.
Our expert chemometricians design appropriate experimentation for developing complex methods requiring principal component analysis (PCA) or partial least squares (PLS) regression if necessary. AMRI also has significant experience with detecting and quantifying minor amounts of amorphous or crystalline forms in both drug substances and drug products. We have successfully transferred many types of methods into our laboratory, and we can also transfer developed methods to your production site.