IUPAC Chemical Name Code Chemical Structure Process Degradation Impurity Sourcemechanism Section 23SJustification of SpecificationsIn addition to other tests controls for drug substance sh ID: 361667
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3.2.S BSTANCEcterAll potntil impuitihould belistd in a I U AC Chmical Name C ode # C h e cal Structure P r o ce ss tion S ou rce /m ec h a nism ectionionddition to othsts, ontols substshould inludetions d idntid unidntid, unspnd impuitito theor Istryitis instation thell spd idntid impuitilongwith tion thhold QT)should bed in abullow: Chemical Name Code # MDD QT (%) QT (TDI) Regulatory QT Threshold (%)* Proposed AC (%) Justification if proposed AC (%) � Regulatory QT Threshold (%)** *Based on lower intake of impurity from QT (%) or QT (TDI). If QT (TDI) is lower express as %.eferethetion suppotiveis pjustition. Ths justition my inludetheollowings ofnd should beludrecin theplition not refto 1. d propoon or do notl obd drugprodu2. purica3. propoon or purd bycieite4. d propoon or do notate substmonoph thontins accer spd impuitis, thmonoph imitilongwith othr potntil impus shoud belistd in dsubstimpuititions.: Thshould belisttivetion timimpuitis should not beregulatory threshold l should be quompisonwith Relative Retention Time Code # MDD IT (%) IT (TDI) Regulatory IT Threshold (%)* Proposed AC (%) Justification if proposed AC (%) � Regulatory IT Threshold (%) *Based on lower intake of impurity using IT (%) or IT (TDI). If IT (TDI) is lower express as %.cceimpus should not beregulatory T. *Based on lower intake of impurity from IT (%) or IT (wt). If IT (TDI) is lower express as %. MDD IT (%) IT (TDI) Regulatory IT Threshold (%)* Proposed AC (%) Not acceptable if proposed AC (%) � Regulatory IT Threshold (%) RODUionAll potntitionts should belistd in abullowistingntition I U P AC Chmical Name C ode # C h e mi cal Structure D e g ra d a tion odu S ou rce /m ec h a nism ectionionddition to othsts, ontols should inludeions d idntid, spd unintid, unsptottion pts.to theor Istryitis ing PrIdentified Degradation Products (Shelf Life)tion thell spdegradation productslongwith tion thhold QT)should bed in alow: Chemical Name Code # MDD QT (%) QT (TDI) Regulatory QT Threshold (%)* Proposed AC (%) Justification if proposed AC (%) � Regulatory QT Threshold (%)** *Based on lower intake of impurity from QT (%) or QT (TDI). If QT (TDI) is lower express as %.eferethetion suppotiveis pjustition. Ths justition my inludetheollowings ofnd should beludrecin theplition1. d propoon or degradation productdo notl obd drugprodu2. degradation productica3. propoon or degradation productd bycieite4. d propoon or degradation productdo notate productmonoph thontins accer spd impuitis, thll Umonoph imitilongwith othr potntil degradation productsshoud belistd in dproduct degradation product tions.UnidentifiedDegradation Products: Thshould belisttivetiondegradation productshouldnot beregulatory threshold l should be quompisonwith Relative Retention Time Code # MDD IT (%) IT (TDI) Regulatory IT Threshold (%)* Proposed AC (%) Justification if proposed AC (%) � Regulatory IT Threshold (%) *Based on lower intake of impurity using IT (%) or IT (TDI). If IT (TDI) is lower express as %.Degradation Productsccedegradation productsshould not beregulatory threshold *Based on lower intake of impurity from IT (%) or IT (wt). If IT (TDI) is lower express as %. MDD IT (%) IT (TDI) Regulatory IT Threshold (%)* Proposed AC (%) Not acceptable if proposed AC (%) � Regulatory IT Threshold (%)