impurities in new drug products

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Impurities in New Drug ProductsIllustration of Thresholds for Reporting, Identification, and Qualification ofDegradation Products in New Drug Products as a Function ofMaximum Daily Dose 1Percentage of Drug Substance1.000.800.600.400.20ReportingIdentificationQualification0.000 500 1000 1500 2000 2500Maximum Daily Dose Expressed in mg of Drug SubstanceExpanded Scale:1.00Percentage of Drug Substance0.800.600.400.20ReportingIdentificationQualification0.000 5 10 15 20Maximum Daily Dose Expressed in mg of Drug Substance1 Note : Actual threshold values should be taken from the preceding table in this attachment.8
Impurities in New Drug ProductsAttachment 2: Illustration of Reporting Degradation Product Resultsfor Identification and Qualification in an ApplicationThe attachment is only illustrative and is not intended to serve as a template howresults on degradation products should be presented in an application file. Normallyraw data are not provided.Example 1: 50 mg Maximum Daily DoseReporting threshold: 0.1%Identification threshold: 0.2%Qualification threshold: 200 µg'Raw' Result(%)ReportedResult(%)(ReportingThreshold =0.1%)Total DailyIntake (TDI)of theDegradationProduct(roundedresult in µg)IdentificationThreshold0.2%exceeded?ActionQualificationThreshold200 µg TDIexceeded?0.04 Not reported 20 None None0.2143 0.2 100 None None0.349 0.3 1 150 Yes None 10.550 0.6 1 300 Yes Yes 1Example 2: 1.9 gram Maximum Daily DoseReporting threshold: 0.05%Identification threshold: 2 mgQualification threshold: 3 mg'Raw' Result(%)ReportedResult(%)(ReportingThreshold =0.05%)Total DailyIntake (TDI)of theDegradationProduct(roundedresult in mg)IdentificationThreshold2 mg TDIexceeded?ActionQualificationThreshold3 mg TDIexceeded?0.049Notreported1 None None0.079 0.08 2 None None0.183 0.18 1 3 Yes None 1, 20.192 0.19 1 4 Yes Yes 19
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