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Stability testing design factors

The application should state the rationale for the design of the in-use stability tests performed. The procedures used should be fully validated. One key factor is that the test should simulate the use of the product as far as practicable. This should include any reconstitution or dilution prior to use. Aliquots should be removed in an appropriate manner following, as far as possible, the usage pattern that will be encountered in practice. Physical (color, clarity, closure integrity, particulate matter, and particulates/particle size), chemical (assays for active ingredient, antioxidants and... [Pg.657]

TABLE 12 Testing Schedule for Matrixing in Factor Stability Study Design... [Pg.599]

Bracketing is the design of a stability schedule such that only samples on the extremes of certain design factors (e.g., strength, container size, and/or fill) are tested at all time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. [Pg.451]

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