This function focuses on identifying, characterizing, and quantifying polymorphic forms of APIs and intermediates, which is critical for stability, solubility, bioavailability, and manufacturability. The data support formulation development, process control, and regulatory submissions.
Key Deliverables
- Polymorph Identification: Detecting all solid forms using XRPD, DSC, and IR spectroscopy.
- Quantification of Polymorphic Forms: Measuring the relative amounts of different polymorphs in a sample.
- Stability & Conversion Studies: Assessing polymorphic stability under varying temperature, humidity, and stress conditions.
- Impact on Bioavailability & Processability: Linking polymorphic forms to solubility, dissolution, and manufacturability.
- Regulatory Support: Providing reports and validated data for IND, NDA, ANDA, DMF submissions.
- Integration with Formulation & Manufacturing: Guiding process design and ensuring consistent quality of the final API.