ANDAs impurities in drug substances - Pharmanet
ANDAs impurities in drug substances - Pharmanet
ANDAs impurities in drug substances - Pharmanet
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Draft-Not for Implementation323324325326327328329330331332333334335336337338339340341342343344345346347348349ATTACHMENT IIIGlossary of TermsAcceptance Criteria: Numerical limits, ranges, or other suitable measures for acceptance of theresults of analytical procedures.Chemical Development Studies: Studies conducted to scale-up, optimize, and validate themanufactur<strong>in</strong>g process for a <strong>drug</strong> substance.Drug Substance: The designated therapeutic moiety. See also the def<strong>in</strong>ition <strong>in</strong> 21 CFR 314.3.Enantiomers: Compounds with the same molecular formula as the <strong>drug</strong> substance, which differ<strong>in</strong> the spatial arrangement of atoms with<strong>in</strong> the molecule and are non-superimposable mirrorimages.Extraneous Substance: An impurity aris<strong>in</strong>g from any source extraneous to themanufactur<strong>in</strong>g process.Genotoxicity Tests: Genotoxicity tests can be def<strong>in</strong>ed as <strong>in</strong> vitro tests designed to detectcompounds that <strong>in</strong>duce genetic damage directly or <strong>in</strong>directly by various mechanisms.(Compounds which are positive <strong>in</strong> tests that detect such k<strong>in</strong>ds of genetic damage have potential tobe human carc<strong>in</strong>ogens and/or mutagens, i.e., may <strong>in</strong>duce cancer and/or heritable damage.)Herbal Products: Medic<strong>in</strong>al products conta<strong>in</strong><strong>in</strong>g, exclusively, plant material and/or vegetable<strong>drug</strong> preparations as active <strong>in</strong>gredients. In some traditions, materials of <strong>in</strong>organic or animal orig<strong>in</strong>may also be present.Identified Impurity: An impurity for which a structural characterization has beenachieved.Impurity: Any component of the <strong>drug</strong> substance that is not the chemical entity def<strong>in</strong>ed as the<strong>drug</strong> substance.Impurity Profile: A description of the identified and unidentified <strong>impurities</strong> present <strong>in</strong> a <strong>drug</strong>substance.Intermediate: A material produced dur<strong>in</strong>g steps of the synthesis of a <strong>drug</strong> substance that mustundergo further molecular change before it becomes the <strong>drug</strong> substance.J:\!GUIDANC\2452DFT.WPDJuly 21, 199814