 Solid Form ScreeningConsistency and quality of any active pharmaceutical ingredient (API) starts with solid form screening. Because the majority of APIs exhibit polymorphism, the FDA requires polymorphic studies be conducted prior to NDA filing. By studying and understanding the polymorphs of the API, and/or selecting the most viable salt, we deliver manufacturing consistency for our clients, better control of clinical supplies, and broader IP protection. Our highly skilled staff will conduct hundreds of scientifically crafted experiments to seek out the existence of polymorphs and produce viable salt candidates. Services include: Batch Profiling- Full characterization of starting solid
- Solubility assessment in a range of solvents
Salt Screening / Co-Crystallization- Selection of counter ions and/or co-formers
- Extensive characterization of the resulting products and selection of the most viable salt
Polymorph Screening- Scientific design & execution of polymorph screening experiments
- Generation of amorphous material
- Polymorph scale-up and full characterization
- Relative stability mapping of different forms
Crystallization Development- Evaluate the impact of solvent on morphology
- Evaluate the cloud point and metastability zone
- Investigate the effect of crystallization parameters and seeding on final partical size distribution and morphology
- Develop an optimal crystallization and isolation process
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