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Genotoxic impurities control strategy

An example of a quality by design approach is illustrated by the control strategy to limit the potential genotoxic aryl nitroso and hydrojylamine impurities (5 and 6 in Scheme 8.5) arising from the reduction of an aromatic nitro-compound developed by Looker et al °... [Pg.146]

Basis for specification limits (including batch history, qualification of specified impurities with particular control strategy for genotoxic impurities)... [Pg.549]

See other pages where Genotoxic impurities control strategy is mentioned: [Pg.535]    [Pg.39]    [Pg.16]    [Pg.17]    [Pg.17]    [Pg.3]    [Pg.4]    [Pg.4]    [Pg.182]    [Pg.289]    [Pg.175]    [Pg.176]    [Pg.178]    [Pg.529]    [Pg.586]    [Pg.642]   
See also in sourсe #XX -- [ Pg.178 ]



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Control: strategy

GENOTOXIC

Impurities control

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