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Stability-indicating method conditions

A stability-indicating method is a validated quantitative analytical procedure that can detect the changes with time in the pertinent properties of the drug substance and drug product under defined storage condition. A stability-indicating assay method accurately measures the active ingredient(s) without interference from other peaks and is sensitive... [Pg.336]

Storage conditions, including temperature, humidity (if applicable). Testing frequency, including time points for each storage condition Tests to be performed at each test station Test method, which must be validated and stability-indicating Acceptance criteria, which may be for information only ... [Pg.218]

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See also in sourсe #XX -- [ Pg.146 , Pg.147 , Pg.148 ]

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Conditional stability

Indicator methods

Stability methods

Stability-indicating method stress testing conditions