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Stability testing is useful for:
- Guiding formulation development
- Selecting packaging materials
- Defining expiration dating
- Selecting labeling text
- Monitoring the quality of marketed formulations using a sampling of batches made during production manufacturing
Stability testing involves storing samples, which are packaged in representative container-closure systems, at various conditions, then testing the samples at various time intervals for attributes that may indicate changes in sample quality. Examples of tests that may indicate changes in quality are:
- Content/potency determinations
- Measurements of impurities
- Release rate determinations
- pH measurements
ASI provides the following services to support stability testing:
- Study design, in cooperation with the client
- Protocol development for client approval
- Storage of stability samples (alternatively, storage may be performed by the client and ASI may receive samples for testing)
- Testing of stability samples
- Interim stability reports, provided after each testing interval
- A final stability report after the last testing interval
- QA review of reports and data (if GMP compliance is requested)
For additional information regarding the available storage conditions provided at ASI click here.
In addition to the storage conditions listed, ASI is able to store nutraceutical samples at ambient conditions, such as in a cabinet with no temperature or humidity control.
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