Stability & Degradation Studies
Stability Studies
We provide stability testing under ICH guidelines to evaluate product integrity over time, combining chemical, structural, and thermal analyses for a complete stability profile.
Benefit
- Full picture of chemical and structural stability
- Early detection of degradation pathways
- Regulatory-compliant stability packages for IND, IMPD, BLA/MAA filings
Techniques & Capabilities
ICH stability protocols
Accelerated & long-term
RP-HPLC & SE-HPLC
Monitoring degradation and aggregation
LC/MS
Detection of chemical modifications (oxidation, deamidation, clipping)
Forced degradation studies
Heat, pH, oxidative, photostability
DSC
Thermal stability and unfolding transitions
Biophysical tools (CD, DLS)
Secondary structure and aggregation monitoring