| Characterization of the Active Pharmaceutical Ingredient (API) is critical to designing a successful formulation approach. When properties are correctly evaluated in the preformulation stage, potential formulation & stability problems are minimized. For this reason, CoreRx takes analytical development very seriously, and brings unmatched expertise to this step in the process. A number of tests and services are provided in the characterization and final drug candidate selection processes.
Representative Preformulation Services:
Particle Size
Solubility Profile
Partition Coefficient
Thermal Analysis
Hygroscopicity
Chemical & Physical Stability Evaluation
Polymorphism
Salt Selection
Impurity identification
Additionally, drug potency and impurity assay development and/or validation are available, as well as methods transfer and method evaluation/optimization. Other potential issues will be addressed by our expert staff with appropriate testing and evaluation. CoreRx ensures complete transparency in every step of the preformulation process so you can trust that your compound is in the best hands.
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