Stability and Solubility Studies

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

• Solid State Stability

  - 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)