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Accelerated stress stability studies

Accelerated or stress stability studies for the purpose of predicting sample shelf life at normal conditions have been investigated for many years. In addition, some examples of stress stability studies for sample comparison have been described. Goldberg and Nightingale (25) compared the stability of aspirin in a combined dosage form with propoxyphene. The hydrolysis... [Pg.241]

Figure 1 Cartoon illustration of hypothetical chromatograms from stress testing (upper) and accelerated or long-term stability studies. Peaks A-I represent all the degradation products from stress-testing studies under various stress conditions and are therefore classified as potential degradation products. Peaks B-E and G represent the products that form at significant levels during formal stability studies and are therefore classified as the actual or relevant degradation products. Figure 1 Cartoon illustration of hypothetical chromatograms from stress testing (upper) and accelerated or long-term stability studies. Peaks A-I represent all the degradation products from stress-testing studies under various stress conditions and are therefore classified as potential degradation products. Peaks B-E and G represent the products that form at significant levels during formal stability studies and are therefore classified as the actual or relevant degradation products.
Once the formulation scientist has narrowed the list of excipients to test in a formulation, an accelerated stability study is initiated. In this study, potential formulations are exposed to conditions such as elevated temperature, harsh light, mechanical stress, and freezing to assess which formulation provides the most stability to the active protein. [Pg.294]

Accelerated stability studies are potentially problematic for at least three reasons. Stress testing conditions may exceed the temperature of a polymorphic phase transition or dehydration. The use of accelerated conditions may make a relaxation of a metastable phase more rapid due to the increased molecular mobility. Finally, the relative humidity of the station may be in the range sufficient to cause a pseudopolymorphic transition due to dehydration or hydration. It is sobering... [Pg.173]


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See also in sourсe #XX -- [ Pg.39 , Pg.314 , Pg.479 , Pg.480 ]




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