Whitepaper
API Crystallization
14 Jul 2022
en
De-Risking Your API for Real-World Conditions
Comprehensive stability and solubility studies are essential for understanding how an API behaves under real-world pharmaceutical development conditions.
Evaluation of physical form integrity and degradation pathways across environmental stresses.
Identification of risks such as salt deliquescence, form changes, and amorphous crystallization.
By systematically probing vulnerabilities, our studies help define the conditions that may impact formulation, manufacturing, and long-term product stability.
Identifying risks early prevents bioavailability issues and costly late-stage redevelopment.
API Stability Testing
Stress testing under acid, base, hydrolysis, oxidation, elevated temperature, and light exposure to identify degradation pathways.
Assessment of polymorphic stability and physical form integrity across temperature and humidity conditions.
Targeted stability testing across controlled temperature and humidity profiles to determine degradation susceptibility.
Advanced Solubility Profiling
Determination of both transient and equilibrium solubility behavior across physiologically relevant environments.
Evaluation of solubility across physiological pH ranges to support formulation and absorption predictions.
Solubility measurements in simulated fluids including FaSSGF, FaSSIF, and FeSSIF.
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Our capabilities span three specialized platforms:
Small Molecule
Crystal Bio Solutions
Crystal NAX
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