Solution state stability is a critical part of the drug development process along the path to producing robust clinical supplies. Our qualified scientists have the capabilities to develop stability protocols from a variety of different stability indicating approaches, such as forced degradation and other stress testing.
Forced degradation (or stress testing) generally involves exposure of drug substances to heat, humidity, photolytic, and other specific client requested conditions. For solution state studies the drug substance is exposed to an array of pH values. The experimental samples manufactured are then put into our fully validated and monitored stability chambers to provide data that all proposed analytical methods are stability indicating, meaning the methods are capable of detecting the loss in content of the active component and any subsequent increase in degradation products.
Solution-State Stability Services:
- Elevated temperature/Forced degradation studies
- Photolytic stability
- Oxidative stability
- Specially – requested conditions
VxP Pharma offers complete stability program management in support of preformulation studies all the way to post-marketing programs. We offer a secure, DEA-licensed stability suite that covers all ICH conditions, as well as photostability and custom conditions—with over 35,000 cubic feet of stability storage space.
We provide fully validated monitoring systems, redundant chamber systems and 100% backup power supply to ensure an optimally-controlled, fully compliant cGMP environment for QC testing and sample storage. Our scientists work closely with the QA group to ensure rapid turnaround of accurate, QA-reviewed data.
Our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.