Considerations for Specific Dosage Forms

The following list of parameters for each dosage form is presented as a guide for the types of tests to be included in a stability study. In general, appearance, assay, and degradation products should be evaluated for all dosage forms. 

The list of tests presented for each dosage form is not intended to be exhaustive, nor is it expected that every listed test be included in the design of a stability protocol for a particular drug product (e.g., a test for odor should be performed only when necessary and with consideration for analyst safety). Furthermore, it is not expected that every listed test be performed at each time point. 

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