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Impurities in drug products

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]

Organic impurities in drug products origin, control and measurement... [Pg.21]

Waterman K, Adami R, Hong J. Impurities in Drug Products in, Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Ahuja, SA, San Diego Academic Press, 2003 75-88... [Pg.454]

For the analytical control of enantiomeric impurities in drug products (and intermediates) in the course of quality control. In these cases the analytical method employed should enable accurate determination of enantiomeric impurities in the... [Pg.348]

Table 2 ICH Q3B(R) reporting and identification thresholds for impurities in drug product... Table 2 ICH Q3B(R) reporting and identification thresholds for impurities in drug product...
Ethical, economic, and competitive reasons, as well as those of safety and efficacy, support the need to monitor impurities in drug products.9 However, monitoring impurities and controlling these impurities mean different things to different people or to the same people at different times, even those in the pharmaceutical sciences and industry.2 A unified terminology is necessary to assure that everyone uses the same vocabulary when addressing questions related to impurities. In this context, the leadership provided by ICH is very helpful. [Pg.7]

VIII. ANALYTICAL METHODOLOGY FOR IMPURITIES IN DRUG PRODUCT... [Pg.27]

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Steering Committee, July 2000, Q3B(R) Impurities in New Drug Products, and ANDAs Impurities in Drug Products, Federal Register, 64, 2 (1/5/ 1999) 516... [Pg.37]

LOD/LOQ/Low-Level Linearity for Specified Impurities in Drug Product (Spiking Experiment)... [Pg.219]

See other pages where Impurities in drug products is mentioned: [Pg.23]    [Pg.25]    [Pg.27]    [Pg.29]    [Pg.31]    [Pg.33]    [Pg.35]    [Pg.37]    [Pg.39]    [Pg.41]    [Pg.43]    [Pg.45]    [Pg.103]    [Pg.172]    [Pg.358]    [Pg.732]    [Pg.290]    [Pg.6]    [Pg.8]    [Pg.11]    [Pg.12]    [Pg.27]    [Pg.29]    [Pg.33]    [Pg.33]    [Pg.75]    [Pg.75]    [Pg.76]    [Pg.77]    [Pg.79]    [Pg.81]    [Pg.83]    [Pg.85]    [Pg.85]    [Pg.87]    [Pg.115]   
See also in sourсe #XX -- [ Pg.33 , Pg.34 , Pg.35 , Pg.75 , Pg.76 , Pg.77 , Pg.78 , Pg.79 , Pg.80 , Pg.81 , Pg.82 , Pg.83 , Pg.84 , Pg.85 , Pg.86 , Pg.87 ]



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