Stability Testing and Storage
Capzer Pharmaceuticals provides stability testing and stability storage support to pharmaceutical and nutraceutical clients for their product development and commercial goods. We meet the requirements for stability studies, shelf life testing and shelf life determination. The Stability studies are conducted under ICH stability conditions following client supplied methods, compendial methods or methods that have been developed and validated in our own laboratory.
Stability testing is conducted for various drug formulations and nutraceuticals including, but not limited to tablets and capsules. Capzer supports long and short-term (accelerated) stability programs as well as photostability programs for Research & Development and commercial products.
Our stability storage chambers has a total storage capacity of 1000 cu ft and are continuously monitored supported by external back-up power generators in the event of power failure. We support the following storage conditions:
- 25°C/60% RH (Controlled Room Temperature)
- 30°C/65% RH (Intermediate)
- 40°C/75% RH (Accelerated)
- Photo-Stability, ICH Q1b (Option 2)
Capzer Pharmaceuticals brings years of experience performing all types of analytical testing on many pharmaceutical and biopharmaceutical substances and products. We maintain the highest level of quality and attention to detail to our clients to assure that their stability program will be successfully executed and that results will be delivered on time.
We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025 accredited.