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 35,000 cubic feet of stability storage space (which is the equivalent of 10 53-foot tractor trailers).
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
- Specially-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