ANDAs impurities in drug substances - Pharmanet
ANDAs impurities in drug substances - Pharmanet
ANDAs impurities in drug substances - Pharmanet
- No tags were found...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Draft-Not for Implementation350351352353354355356357358359360361362363364365366367368369370371372373374375376377Ligand: An agent with a strong aff<strong>in</strong>ity to a metal ion.Mass Balance: The process of add<strong>in</strong>g together the assay value and levels of degradationproducts to see how closely these add up to 100 percent of the <strong>in</strong>itial value, with dueconsideration of the marg<strong>in</strong> of analytical precision.New Drug Substance: The designated therapeutic moiety that has not been previously registered<strong>in</strong> a region or member state (also referred to as a new molecular entity or new chemical entity). Itmay be a complex, simple ester, or salt of a previously approved <strong>drug</strong> substance.Polymorphism: The occurrence of different crystall<strong>in</strong>e forms of the same <strong>drug</strong> substance.Potential Impurity: An impurity that, from theoretical considerations, may arise from or dur<strong>in</strong>gmanufacture. It may or may not actually appear <strong>in</strong> the <strong>drug</strong> substance.Qualification: The process of acquir<strong>in</strong>g and evaluat<strong>in</strong>g data that establishes the biological safetyof an <strong>in</strong>dividual impurity or a given impurity profile at the level(s) specified.Quantitative Structure Activity Relationship (QSAR): Used for rationalization and predictionof <strong>in</strong> vivo mammalian toxicity of chemicals on the basis of their overall and/or local properties, asdef<strong>in</strong>ed by their chemical structure and evaluated by us<strong>in</strong>g an appropriate data base and modules.Reagent: A substance, other than a start<strong>in</strong>g material or solvent, that is used <strong>in</strong> the manufacture ofa <strong>drug</strong> substance.Safety Information: The body of <strong>in</strong>formation that establishes the biological safety of an<strong>in</strong>dividual impurity or a given impurity profile at the level(s) specified.Solvent: An <strong>in</strong>organic or an organic liquid used as a vehicle for the preparation of solutions orsuspensions <strong>in</strong> the synthesis of a <strong>drug</strong> substance.Specification: A list of tests, references to analytical procedures, and appropriate acceptancecriteria that are numerical limits, ranges, or other criteria for the tests described. It establishes theset of criteria to which a <strong>drug</strong> substance or <strong>drug</strong> product should conform to be consideredacceptable for its <strong>in</strong>tended use. Conformance to specifications means that the <strong>drug</strong> substanceand/or <strong>drug</strong> product, when tested accord<strong>in</strong>g to the listed analytical procedures, will meet the listedacceptance criteria. Specifications are b<strong>in</strong>d<strong>in</strong>g quality standards that are agreed to between theappropriate governmental regulatory agency and the applicant.J:\!GUIDANC\2452DFT.WPDJuly 21, 199815