Stability

AMRI offers customized stability assessment services for APIs, isolated process intermediates and formulated drug products which include developmental and packaging studies, formal stability protocol design, chromatographic analysis, wet chemistry and dissolution testing.  AMRI’s stability facilities are licensed for storage of controlled substances (DEA schedule I through 5).

Qualified stability chambers are available on site at standard ICH conditions of:

• -20 °C
• 5 °C
• 25 °C/60% RH
• 30 °C/65% RH
• 40 °C/75% RH
• -70 °C

AMRI also has internal capability for photostability studies (option 2) and can coordinate with qualified third-party storage sites.