Charles River can perform multiple salt screens to improve an API or IMP’s solid form characteristics, such as solubility/dissolution, stability (both chemical and polymorphic) and hygroscopicity. Salts are characterized using a variety of techniques and their solubility assessed, thus providing early directional data for the selection of the optimum salt. We take an adaptive approach to help you meet your goals in the shortest possible timelines.
With the ability to scale up salts in jacketed vessels from 250mL to 20L, Charles River can provide sufficient material for all pre-GMP work if required and liaise with third parties to ensure the correct solid form is produced. Appropriate documentation is provided to facilitate GLP services.
Characterization of Salts
- Determination of optimum conditions for production of salt using metastable zone width properties
- Thermodynamic solubility measured in a range of aqueous buffers
- Dissolution rates assessed in a variety of biologically relevant media
- Long-term stability trials under ICH guidelines
- Forced degradation studies including light and solution stability assessment
- In-house micronization and particle size determination to meet specified requirements