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Stability Studies
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Services
Xcelience gathers information from our clients to establish the correct parameters of our Stability Studies, including appropriate test conditions, the duration of the stability study, the testing intervals, and the analytical methods. These processes vary with the type of product and type of study (scientific or regulatory.) Xcelience has extensive experience at both.
Information is entered into our Stability Laboratory Information Management (SLIM) System – a state-of-the-art database designed specifically for stability operations. SLIM allows us to design a protocol specific to each client’s product needs. This includes:
 | | Specific sample information (dosage form, dosage strength, lot/batch #) |
| | Storage conditions |
| | Number of samples to be placed at each storage condition |
| | Analytical testing intervals |
| | Number of samples to be pulled at each testing interval |
| | Analytical methods |
| | Data entry at conclusion of testing intervals |
| | Submission quality reports |
SLIM is a closed network that meets the FDA’s standards for 21CFR Part 11 compliance, meaning, no unauthorized person can access SLIM to enter or alter information. Nothing within SLIM can be changed except by personnel with the correct access level, and every change is logged into a complete audit trail. Hence, clients can feel certain that their data are secure.
Capabilities/Equipment
We have the capability to store stability samples at a variety of temperature and humidity conditions that meet the standards of the International Conference of Harmonization (ICH), including:
| | 2°-8°C |
| | 25°C/40%RH |
| | 25°C/60%RH |
| | 30°C/60%RH |
| | 30°C/65%RH |
| | 40°C/15%RH |
| | 40°C/75%RH |
Our stability chambers are fully validated, placed in secure areas, and continually monitored. The chambers are also equipped with alarms that notify staff when conditions move out of specification. This ensures that appropriate personnel are notified immediately so correct conditions can be restored within the time-frame required by our SOPs. |
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