Pharmaceutical
Stability Studies and Testing Services

Boston Analytical offers a wide range of stability testing services in compliance with FDA and ICH guidelines.

• Long-term stability studies
• Accelerated stability studies
• Photostability studies

Stability samples are tracked and scheduled for testing by our computerized stability database. This system tracks the status of your sample from receipt through storage, testing and generation of reports.

A state of the art photostability chamber is available. This chamber has the capability to provide fluorescent light intensities from 1,000 to 10,000 Lux per hour. Samples stored at 10,000 Lux can satisfy the ICH Option 2 protocol for light exposure in as few as five days. UV light exposure is done simultaneously.

Storage Conditions

• 5 ° C.............................Refrigerated Condition
• 25° C...........................Ambient Humidity
• 25° C / 60% R.H. .....Primary ICH Long Term Condition
• 30º C / 65% R.H. ......Intermediate ICH Condition
• 30° C / 60% R.H.......Intermediate ICH Condition
• 40° C / 75% R.H. .....Accelerated ICH Condition
• Photostability..............ICH Option 2
• Custom Storage Conditions (available upon request)