Services

Stability Storage & Testing

QCL offers stability storage and testing as part of our stability management services for drugs substances and drug products from development to market. 

 

Our experienced team of chemists allows us to offer development/validation of stability indicating methods, forced degradation studies, impurity/degradant characterization, in addition to routine analytical and microbiological testing. 

 

QCL can completely manage your study from start to finish beginning with protocol creation and management and ending with data evaluation including stability summary tables (FDA format or custom), data trending, and expiration date prediction.  With our recent expansion QCL has all of the typical ICH storage conditions available (25°C/60%RH, 30°C/65%RH, 40°C/75%RH, 5°C, -20°C, Photostability (Option 2)).  Ask about our other capabilities including: climatic zones III and IV storage, 25°C/40%RH for semi-permeable containers, thermal cycling, and freeze/thaw studies.  All conditions are continuously monitored by the Veriteq Viewlinc Environmental Monitoring, Alarm Notification and Reporting System and is equipped with generators for power backup.

 

Previous Next