Chemical and physical stability
The intent of the stability study is to evaluate the chemical and physical stability of the API 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.
Solid State Stability
At different temperature and humidity
At different temperature and humidity– test for degradation
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)