GRAM Laboratories offers a comprehensive cGMP-compliant stability studies program, including preparation of stability study protocols, storage and inventory of samples, sample pull, sample analysis, statistical analysis of stability data, and estimation of expiration date.  Accelerated storage conditions in strict adherence to ICH guidelines are available for conduct of stability studies.  Customized temperature and humidity conditions based on the specific needs of the customer can also be accommodated on a case by case basis.  The following storage conditions are available for conduct of stability studies.

• 25ºC/60% RH
• 30ºC/65% RH
• 40ºC/75% RH
•  2-8ºC
• Photostability studies (ICH condition)
• Ambient Temperature (Shelf-life)

STABILITY STUDIES

SERVICE

SERVICES: Stability Studies