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Impurities in drugs

Presence of specific substances as impurities in drug substances... [Pg.409]

PRESENCE OF SPECIFIC SUBSTANCES AS IMPURITIES IN DRUG SUBSTANCES... [Pg.425]

Impurities in drug substances and drug products continue to be a source of great concern, discussion, debate, and research. " These concerns and debates typically center on the potential safety risks associated with impurities due to contamination and the setting of acceptance criteria. However, the bulk of the work being performed in the pharmaceutical industry, with respect to impurities, is focused on the isolation, identification, qualification and quantification of impurities that are found as a result of the manufacturing process or through chemical decomposition. On the... [Pg.359]

Starting materials, solvents, intermediates, degradation products, and by-products are often organic impurities found in drug substances and excipients, while excipient impurities, solvents, by-products, degradation products, and container/closure adducts may be found as organic impurities in drug products. [Pg.362]

Gorog, S. (2000). Identification and Determination of Impurities in Drugs. Vol. IV, Elsevier, Amsterdam. [Pg.299]

Mol et al. applied MEKC coupled with ESI—MS successfully for the analysis and characterization of impurities in drug substances. [Pg.435]

NMR has been used extensively to quantify the main component of a mixture relative to an internal standard, or the level of individual impurities after their explicit identification. The main application area is that of impurities in drugs, and this has been reviewed by Szantay and Demeter. The reliability... [Pg.232]

Organic impurities in drug substance origin, control, and measurement... [Pg.1]

See other pages where Impurities in drugs is mentioned: [Pg.299]    [Pg.361]    [Pg.430]    [Pg.294]    [Pg.9]    [Pg.273]    [Pg.289]    [Pg.289]    [Pg.453]    [Pg.526]    [Pg.537]    [Pg.569]    [Pg.573]    [Pg.216]    [Pg.218]    [Pg.260]    [Pg.3]    [Pg.5]    [Pg.7]    [Pg.9]    [Pg.11]    [Pg.13]    [Pg.15]    [Pg.17]    [Pg.19]    [Pg.23]    [Pg.25]    [Pg.27]    [Pg.29]    [Pg.31]    [Pg.33]    [Pg.35]    [Pg.37]    [Pg.39]    [Pg.41]    [Pg.43]    [Pg.45]   
See also in sourсe #XX -- [ Pg.52 , Pg.65 ]



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Drug impurities

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