Pharmaceutical Stability Testing
CMC Pharma executes both routine and custom-designed stability studies, allowing the results produced in our lab to better advance your drug program or support your approved drug product.
In addition to a wide range of custom and routine stability studies to determine shelf life, we determine the compatibility of drug product formulations with manufacturing trains (e.g. compounding and holding vessels, processing equipment, transfer tubing, filtration membranes) and container closures to support drug product tech transfer packages and regulatory submissions.
Stability studies can be performed compliant with cGMPs, FDA regulations, and ICH guidance as needed for regulatory submissions.
Stability Studies Include:
- ICH stability studies in-use, long-term storage, accelerate, and forced degradation conditions
- Compatibility studies with product contact materials
- Container closure studies
- Studies at custom conditions
- Evaluating excursions from recommended storage conditions
- High temperature studies (e.g. 60, 70, 80°C) to quickly differenciate stability characteristics of different formulation approaches
Contact Us Today and find out how CMC Pharma can help you!
Whether you are working on a major drug development program or require a small, one-off stability study, CMC Pharma will provide high-quality results.
Send us a message or give us a call at 440-485-1734
Our Stability Capabilities Include:
ICH Stability Conditions
- Frozen (-20°C)
- Refrigerated (5°C)
- Room temperature (25°C/60%RH)
- Intermediate (30°C/65%RH)
- Accelerated (40°C/75%RH)
Additional Stability Conditions
- Freeze/thaw stability
- Photostability (UV and visible)
- Deep freeze (-80°C)
- Extreme/forced (60°C to 80°C) studies
- Additional custom conditions
In-use Studies
- Determine expiry dating after reconstitution or dosage preparation (e.g., Expiry after reconstitution of lyophilized dosage form).
- Determine expiry dating after moving from one storage condition to another (e.g., moving from refrigerated to room temperature).
- Determine material compatibility after dispensing (e.g., IV bag expiry dating)
- Determine in-use shelf life and expiry dating (e.g. after vial puncture)
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