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Genotoxic impurities control

Genotoxic impurities, which are observed in production batches, or for which there are theoretical grounds for believing that they may be present, should be treated with great caution using a much lower acceptance criterion for control. [Pg.6]

A rationale for determination, testing and control of genotoxic impurities. Regulatory Toxicology and Pharmacology, 44, 198-211. [Pg.268]

The pressures on Process Chemistry are mounting rapidly Industry seeks rapid entry into the clinic, postponing development spend until proof of concept, then rapid conunerciaUzation once benefit is established. External and internal trends look for more complete data, deep process understanding, absolute control of genotoxic impurities, establishing of design space and quality by design, and real time control of the process via on line sensors. [Pg.486]

Elder, D. P, Lipczynski, A. M. and Teasdale, A. Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs). J. Pharm. Biomed. Anal. 48 497-507, 2008. [Pg.193]

Lui, Q. D., Chen, K. T., Mcquire, A. M., Aleriza, K. and Kord, S. Analytical control of genotoxic impurities in pazopanib hydrochloride manufacturing. Process. Pharm. Biomed. Anal. 50 144-150, 2009. [Pg.426]

Rationale and quality control for genotoxic impurities in preparation for EIH... [Pg.534]

Rationale and quality controls for genotoxic impurities Certificates of analysis—API... [Pg.535]

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

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]

See other pages where Genotoxic impurities control is mentioned: [Pg.9]    [Pg.13]    [Pg.38]    [Pg.39]    [Pg.250]    [Pg.349]    [Pg.578]    [Pg.14]    [Pg.16]    [Pg.17]    [Pg.17]    [Pg.17]    [Pg.18]    [Pg.1]    [Pg.3]    [Pg.4]    [Pg.4]    [Pg.4]    [Pg.5]    [Pg.294]    [Pg.182]    [Pg.289]    [Pg.144]    [Pg.3]    [Pg.171]    [Pg.178]    [Pg.193]    [Pg.529]    [Pg.535]    [Pg.586]    [Pg.642]    [Pg.1359]    [Pg.295]    [Pg.296]    [Pg.460]    [Pg.175]   
See also in sourсe #XX -- [ Pg.14 , Pg.16 , Pg.17 ]



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GENOTOXIC

Impurities control

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