Last updated: August 23, 2017
No, General Chapter <795> is specific for nonsterile preparations. Footnote (a) under the table indicates that the table represents the maximum Beyond-Use Date (BUD) for compounded nonsterile preparations in the absence of stability information. A Revision Bulletin for <795> was posted on November 22, 2013 (official January 1, 2014) to further clarify this distinction.
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Yes, a strength (potency) over time test determines the amount of active ingredient in a preparation, however, it may not be able to separate the active ingredient from its degradation products and impurities for quantitation depending on the analytical methods used for the test. A stability-indicating method will be able to quantitate the active ingredient and its degradation products or related impurities in the preparation by separating the active ingredient from its degradation products and impurities, and to show a change in the concentration of the active ingredient with increasing storage time. A stability-indicating method is used to determine stability of a drug and used to establish the Beyond-Use Date. (See article, “Strength and Stability Testing for Compounded Preparations.”)