Stability and Shelf Life Services
Quantum offers a complete range of stability testing services to assist you with your stability testing requirements. We can handle your complete stability study needs - from providing the appropriate storage for your samples, to pulling samples at specified intervals , to testing them according to the specified procedures and time table you require. Or, if you prefer, we can analyze samples that you store and send to us at specified testing intervals. All stability studies are carried out in compliance with FDA and ICH guidelines.
Each of our stability chambers operates independently with its own temperature and humidity controls. Temperature and humidity setpoint windows are ±2OC and ±5% RH, respectively. All storage chambers are continuously monitored by 21 CFR part 11 compliant computerized and hardwired security systems. Chambers are also connected to automatic emergency generator power to ensure the integrity of stored samples. If a chamber should go out of specification, an alarm will notify personnel for immediate attention and corrective action.
We have numerous temperature and humidity conditions available in our qualified stability storage chambers, including all conditions needed to comply with the ICH guidelines.
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