Stability and Storage

Maintaining CGMP products in qualified stability chambers is crucial for determining the expiry period and establishing the safety of your products. SK pharmteco Analytical Services offers all ICH* stability storage conditions and has experienced analytical scientists to support all of your CGMP stability requirements. We can transfer or validate your existing analytical methods to support studies. If you don’t have stability-indicating methods, our development scientists can provide them! Our development approach introduces forced degradation early on in the process and places an emphasis on chromatographic conditions that support mass spectrometry for full analytical life-cycle support.

All chambers have controlled access and are fully mapped and qualified. Temperature and humidity are continuously monitored by a validated computerized recorder. Alarms are set for out-of-tolerance events, and notifications are generated and sent to responsible personnel. Every chamber and electronic chart recorder have redundant backup power supplies.
Learn more: Stability and Storage Testing – SK pharmteco

* International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

https://www.ich.org/

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