Solid-State Stability and Polymorph Transformation Studies

Typical full polymorph screening studies require 2–5 grams of API. For mini-screens or early-stage evaluations, as little as 100–500 mg can be sufficient. The exact amount is confirmed during project scoping based on your molecule and the breadth of the study.

Our standard analytical package includes X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and dynamic vapor sorption (DVS). Additional techniques such as solid-state NMR, Raman spectroscopy, and optical microscopy are deployed as needed based on the specific challenges of the compound.

Yes, we design transformation studies that simulate key manufacturing steps such as wet granulation, drying, and compression. These studies help identify critical process parameters that influence polymorph stability and are essential for developing a robust control strategy.

All experiments are conducted with rigorous quality controls, including reference standards, repeat experiments for key conditions, and independent confirmation of solid forms by multiple analytical techniques. Data are reviewed by senior scientists with extensive experience in solid-state chemistry.

Absolutely. Our polymorph screening and stability data are generated in accordance with regulatory expectations for CMC submissions. We can provide CMC-ready documentation, including polymorph control strategies and justification for the selected form, to support IND, NDA, or post-approval changes.