STABILITY STUDIES

Amachems maintains chambers for conducting both non-GMP and cGMP stability studies in accordance with ICH guidelines. Our stability studies are used to:

• determine the robustness of formulation prototypes during early development;
• ascertain the chemical and physical integrity of lead formulations prior to advancement into animal/toxicology studies; and
• assure final formulations meet stability requirements for commercial products as formulations are transitioned to human studies.
  
  

Amachems conducts stability studies on the oral, topical and parenteral dosage forms we manufacture as clinical trial materials for our clients. The chambers/conditions we test for stability at include:

• 25°C / 60% relative humidity (RH)
• 30°C / 65% RH
• 40°C / 75% RH
• -20°C
• 5°C (Refrigerated)
• 60°C
  
  

We also conduct photo stability as necessary using an ATLAS Sunset CPS chamber (conforming to ICH Q1B guidelines).