STABILITY
TESTING
Stability-indicating HPLC methods with forced degradation studies using validated HPLC methods. Evaluate how your compound behaves under acid, base, oxidative, thermal, and photolytic stress conditions to understand degradation pathways and assess shelf-life.
- 01Forced degradation profiling
- 02Shelf-life estimation
- 03Degradation pathway identification
- 04Formulation stability assessment
- 05Storage condition optimization
Stability testing at Standard Analytica uses stability-indicating HPLC methods designed to separate the parent compound from all potential degradation products. The method is validated to demonstrate specificity under each stress condition.
Forced degradation studies expose your compound to accelerated conditions including acidic and basic hydrolysis, oxidative stress (hydrogen peroxide), elevated temperature, and UV/visible light exposure per ICH Q1A/Q1B guidelines.
Results provide critical insight into degradation pathways, help establish appropriate storage conditions, and support shelf-life determination for your compound or formulation.
SAMPLE INTAKE
Your sample is received, logged into our LIMS system, and assigned a unique tracking identifier. Sufficient material is verified for all planned stress conditions.
STRESS EXPOSURE
Sample aliquots are subjected to controlled stress conditions: acid hydrolysis, base hydrolysis, oxidation (H₂O₂), thermal stress, and photolytic exposure per ICH guidelines.
ANALYSIS
Stressed and unstressed control samples are analyzed on our HPLC system. Degradation products are separated, detected, and quantified using the stability-indicating method.
REPORTING
A comprehensive report with degradation profiles, mass balance data, peak purity assessments, and chromatographic overlays for each stress condition is delivered.
SUBMIT A SAMPLE
Ready to evaluate the stability of your compound? Order online or contact our team to discuss your requirements.