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Shelf-life estimation storage below

Shelf Life Estimation for Drug Substances or Drug Products Intended for Storage below -20°C... [Pg.560]

It will be useful to estimate how far from the glass transition temperature an amorphous material can be stored to ensure that the material is kinetically stable over the duration of shelf life. Several rules of thumb have been proposed, of which probably the best known is the Tg - 50 rule for estimating the required storage temperature (Hancock et al. 1995). If this temperature is far below room temperature, storage of the amorphous dmg at that temperature will not be practical, and alternative means of stabilizing the amorphous drug will be needed. (It should be noted that the Tg - 50 rule is a generalization based on concepts such as those detailed above. While many materials do not follow this rule, it is still a useful concept.)... [Pg.30]


See other pages where Shelf-life estimation storage below is mentioned: [Pg.131]    [Pg.158]    [Pg.249]    [Pg.249]    [Pg.222]    [Pg.302]    [Pg.336]   
See also in sourсe #XX -- [ Pg.20 , Pg.72 ]




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