The primary objectives of solid state stability investigations are identification of stable storage conditions for drug product and identification of compatible excipients for the formulation. Solid state stability testing usually requires repetitive testing of the initial bulk lot in parallel with newer bulk lots, therefore adequate material should be set aside for these studies.
VxP Pharma offers solid state studies directed towards investigating or developing process improvements, such as optimizing your candidates’ crystallinity and purity profile.
Solid state reactions are generally much slower and more difficult to interpret than solution state reactions, therefore implementing stress conditions is a critical step in the investigation of stability. Data obtained under multiple given stress conditions are then extrapolated to make a prediction of stability under appropriate storage conditions.
- Elevated temperature/Forced degradation studies
- Photolytic stability
- Oxidative stability
- Specially – requested conditions
VxP Pharma offers complete stability program management in support of preformulation and 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 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.