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Genotoxic impurities

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 final challenge for early screening is the detection of genotoxic impurities and synthetic intermediates which can create occupational/manufacturing as well as patient safety issues. This again is a complex issue because the material screened from a library might be synthesized and purified by different routes to a drug that enters the clinic. These issues are addressed in a later section. [Pg.248]

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

F M F A Guideline on the limits of genotoxic impurities, http //www.emea.europa.eu/ pdfs /human/ swp/519902en.pdf... [Pg.268]

European Medicines Agency, Evaluation of Medicines for Human Use. Guideline on the Limits of Genotoxic Impurities, EMEA/CHMP/QWP/251344/2006. [Pg.378]

SPECIALTY GUIDELINES FOR GENOTOXICITY GENOTOXIC IMPURITIES IN PHARMACEUTICALS... [Pg.256]

TABLE 10.1. Generic Staged TTC Values for Genotoxic Impurities During the Clinical Trial Stage for Pharmaceutical Candidate Compounds ... [Pg.258]

CHMP (2008). CHMP Safety Working Party (SWP) Question Answers on the CHMP Guideline on limits of genotoxic impurities. London, 26 June 2008, Doc. Ref. EMEA/CHMP/SWP/431994/2007 Revision 1, http //www.emea.europa.eu/pdfs/human/swp/43199407en.pdf, 1-3. [Pg.265]

LC/MS/MS methods for trace analysis (e.g., bioanalytical assays, trace genotoxic impurities)... [Pg.195]

In addition, final salt-forming steps can introduce genotoxic impurities. Some examples include formation of methyl chloride as a side reaction of hydrochloric acid in methanol, or esters of methanesulfonic acid as the by-product from the methanesulfonic acid salt formation step in alcoholic solvents. ... [Pg.17]

PhRMA published a draft position paper proposing a classification system for genotoxic impurities and associated limits during each phase of development based on the level of risk these impurities may pose on the safety of subjects participating in clinical trials. This staged TTC concept was also recommended for establishing limits for conunercial products. [Pg.17]

Concerns over the safety of tiny amounts of potential genotoxic impurities in APIs were driven by major advances in analytical instrumentation that allow detection of these impurities at parts per million levels. [Pg.296]

See other pages where Genotoxic impurities is mentioned: [Pg.9]    [Pg.13]    [Pg.38]    [Pg.39]    [Pg.84]    [Pg.250]    [Pg.250]    [Pg.268]    [Pg.349]    [Pg.58]    [Pg.338]    [Pg.777]    [Pg.187]    [Pg.188]    [Pg.573]    [Pg.574]    [Pg.578]    [Pg.257]    [Pg.257]    [Pg.258]    [Pg.14]    [Pg.16]    [Pg.16]    [Pg.16]    [Pg.17]    [Pg.17]    [Pg.17]    [Pg.18]    [Pg.22]   
See also in sourсe #XX -- [ Pg.179 , Pg.182 ]

See also in sourсe #XX -- [ Pg.93 ]

See also in sourсe #XX -- [ Pg.4 ]



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