ABC Laboratories offers complete stability program management in support of IND, clinical, registration stability and post-marketing programs. We offer a secure, DEA-licensed stability suite that covers all ICH conditions, as well as photostability and custom conditions—with over 43,000 cubic feet of stability storage space.
A fully validated Rees monitoring system, redundant chamber systems, and 100% backup power supply ensure an optimally controlled, fully compliant CGMP environment for QC testing and sample storage. Our QC chemists work closely with the QA group to ensure rapid turnaround of accurate, QA-reviewed data.
Storage Conditions
- 25 °C / 60% RH
- 30 °C / 60% RH
- 30 °C / 65% RH
- 40 °C / 75% RH
- -20 °C, 5 °C, 50 °C
- Controlled Room Temperature
- Special Requested Conditions
- Photostability
Physical Testing
- Color Determination
- Container Closure Integrity
- Deliverable Volume
- Particle Size
- Appearance
- Loss on Drying
- Disintegration
- Melting Point
- Boiling Point
- Density
- Friability
- pH
- Turbidity
- Viscosity
- Moisture
- Osmolarity
- Hardness
- Particulates