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Drug substances general stability

Long-term testing Stability studies under the recommended storage condition for the retest period or shelf life proposed (or approved) are performed with several drug substance batches in the stipulate packaging. In the general case, the storage condition is at a temperature of 25°C and 60% relative humidity. [Pg.112]

For drug substances, a retest date is generally determined. The period up to the retest date is a period during which the material is known to adhere to its specification, for example, for assay or degradants. The retest date may be assigned on the basis of real-time stability data obtained at the recommended storage conditions or on the basis of accelerated stability data obtained under more stressful conditions. [Pg.11]

See other pages where Drug substances general stability is mentioned: [Pg.3]    [Pg.84]    [Pg.3]    [Pg.73]    [Pg.169]    [Pg.747]    [Pg.380]    [Pg.391]    [Pg.9]    [Pg.335]    [Pg.336]    [Pg.337]    [Pg.338]    [Pg.338]    [Pg.346]    [Pg.350]    [Pg.64]    [Pg.112]    [Pg.224]    [Pg.11]    [Pg.17]    [Pg.72]    [Pg.696]    [Pg.698]    [Pg.8]    [Pg.229]    [Pg.141]    [Pg.172]    [Pg.462]    [Pg.273]    [Pg.35]    [Pg.95]    [Pg.131]    [Pg.434]    [Pg.77]    [Pg.195]    [Pg.374]    [Pg.495]    [Pg.590]    [Pg.666]    [Pg.302]    [Pg.1685]    [Pg.1686]    [Pg.1785]    [Pg.2222]    [Pg.2227]    [Pg.2270]   
See also in sourсe #XX -- [ Pg.8 ]



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