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Service Overview
Profile: Stability |
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Click here to request a quote for custom work or specialized needs.
The ability to ensure, over time, the stability of physical and chemical properties of a product is critical for labeling, quality control and consumer acceptance.Testing programs to monitor these critical characteristics are governed by strict regulatory guidelines and generally run in accordance with current Good Manufacturing Practices (cGMPs). Specialized expertise, instrumentation and facilities to conduct the full range of testing is required including environmental chambers that can simulate long-term storage conditions. These chambers, which meet ICH standards, enable researchers to evaluate product stability based on real-time, accelerated and long-term protocols. Both temperature and humidity are controlled and the storage conditions are continuously monitored for compliance.
- 10 walk-in and 12 reach-in chambers
| Stability Parameters |
| Test |
Condition |
| Real Time |
25°C / 60% RH |
| Accelerated |
40°C / 75% RH |
| Alternate |
30°C / 65% RH |
| Semi-Permeable (package real time) |
25°C / 35% RH |
| Semi-Permeable (package accelerated) |
40°C / 15% RH |
| Stress |
50°C |
| Stress (fluorescent and UV-A) |
25°C / 60% RH |
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- Nutrient or potency
- Degradation products
- Dissolution
- Organoleptic properties
(appearance, hardness, packaging materials)
- Chemical properties (pH, moisture, weight loss)
- Product release
- Complete USP or international monograph
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Prices are subject to change without notice. Prices are for single samples; volume pricing available. All prices are shown in USD.
*Price for the first sample of a group/prices for each additional sample of that group.
**If initial test is positive, additional fees are required for confirmation. |
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