Chemical and physical stability
The stability study intends to evaluate the API's chemical and physical stability in solution and solid-state. The solid-state evaluation will probe the propensity of form change, crystallization (for amorphous), and deliquescence (for salts). The chemical stability testing will screen the set of conditions in which the API is unstable and could cause difficulties in development.
Our chemical and physical stability services include a range of monitored temperature, humidity, and light stability storage cabinets which comply with ICH Guidelines.
Forced degradation
- Acid
- Base
- Hydrolysis
- Oxidation
- Temperature
- Light
- At different temperature and humidity
Chemical Stability
- At different temperature and humidity– test for degradation
Solubility
Crystal Pharmatech also can measure the solubility of compounds under a variety of conditions. The data obtained from these studies are necessary for obtaining outputs such as preclinical dose number, DCS evaluation, and preclinical decision tree.
Kinetic solubility measurement
Thermodynamic solubility measurement
pH-dependent solubility measurement
Solubility measurements in gastric and intestinal fluid mimetics (FaSSGF, FaSSIF, FeSSIF)
For more information about contract manufacturing organization pharma, please feel free to contact us!
Crystal Pharmaceutical, established in 2010, is a global company with approximately 250 employees and three R&D centers located in Suzhou (China), New Jersey (USA), and Toronto (Canada). Our key differentiator is our integrated and specialized services, including API solid-state research, crystallization, preformulation, formulation development and manufacturing, clinical supply.
