STABILITY/RELEASE TESTING
Prevalere assists our clients with the set-up and conduct of accelerated and long-term stability studies as well as release testing of marketed products for a wide variety of dosage forms.
All services are performed in compliance with Good Manufacturing Practices (GMP) Title 21, Part 211 (Subpart I) as set forth by the FDA in the Code of Federal Regulations (CFR). This compliance includes, but is not limited to, adherence to Standard Operating Procedures and periodic inspection by our Quality Assurance Department.
Accelerated and Long-term Stability Storage Conditions Available:
Temperature: -80°C, -20°C, 5°C, 25°C, 30°C, 40°C, 50°C (temperature cycling in the range of 5°C to 40°C)
Temperature/R.H: 25°C/60% R.H., 30°C/60% R.H., 25ºC/75% R.H., 40°C/75% R.H.
