CS Analytical provides stability storage solutions integrated with analytical capabilities to support client evaluation of key quality attributes of their product over time at anticipated conditions and against a series of environmental challenges. At different stability timepoints, in addition to typical product assessments, test programs may include component physicochemical tests, component dimensional analysis and a custom developed and validated USP <1207> Container Closure Integrity tests in lieu of or in addition to sterility testing after T0. The experienced CS Analytical Team can follow client supplied methods, compendial / standard methods (example ICH, ASTM, USP, EP) or methods that have been developed and validated by our internal staff to very specific client needs. The laboratory is setup to handle all types of drug formulations including, but not limited to, sterile injectable products, tablets, capsules, non-sterile liquids, transdermal products, aerosols, and medical device combination systems.
Our stability and storage chambers are qualified using extensive mapping studies with NIST traceable standards and are continuously monitored by a 24/7 alert system. All critical instrumentation is wired to an external back-up power generator in the event of power failure.
Short and long terms programs can be developed based upon client need that take into account product type, container materials of construction, and overall package and delivery system requirements. More advanced programs that require the development and validation of custom stability indicating methods can be implemented as part of a comprehensive solutions approach.
We offer a variety of routine ICH storage conditions and can also customize programs to a client’s specific condition and time frame. Example of common conditions include:
- Routine ICH Conditions
- 25C/ 60% RH
- 40C/ 75% RH
- 30C/ 65% RH
- Low Temperature Conditions
- Custom Conditions per Client Need