Stability assessment is necessary to determine and/or establish the API or drug product’s shelf life and recommended storage conditions.
LATITUDE’s experience and capabilities in stability testing provides our clients with evidence and data to show how the quality of their API or drug product vary in time in response to environmental and temperature changes.
Available stability services that support ICH guidelines:
- Stress testing
- Batch selection
- Container closure system
- Specification- covers physical, chemical, biological and microbiological attributes
- Drug-substance stability testing
- Long-term studies – e.g., every 3 months for the first year, 6 months for the second year
- Accelerated stability – e.g., 3 time points for a 6-month study
- Intermediate stability – e.g., 4 time point for a 12-month study
- Comparative stability
- Forced degradation studies
- Formulation evaluation stability testing
- Temperature and humidity testing
- Analytical Method Transfer
Contact us to discuss your stability testing needs.