Our clients benefit from advanced technologies for analytical testing, such as spectroscopy (IR, Raman, solution and solids NMR); diffraction (XRPD, single crystal structures); mapping and imaging (Raman, IR, NIR, EDS); thermal (microcalorimetry, DSC, TGA, TG-IR); mass spectrometry; microscopy (polarized-light, SEM); and micromeritics (particle size and surface area). Our laboratory is operated following current Good Manufacturing Practices (cGMPs) regulations as codified in 21 CFR Part 211.
Method development, validation and transfer services employ both qualitative and quantitative methods for API and drug product. A range of investigational studies can assess a variety of materials, including drug delivery devices, and assist in determining the origin of issues such as batch-to-batch variability, dissolution issues, bioavailability, flow properties, content uniformity and the presence of unknown materials.
Our analytical experts also support preformulation activities, such as pKa/logP/logD; equilibrium solubility and establishing pH solubility profiles; dissolution testing of powders, intrinsic, and drug product; assay and impurity profiles, including the isolation and identification of impurities during crystallization process development activities; and excipient compatibility to support drug product formulation design.