impurities in new drug products
impurities in new drug products
impurities in new drug products
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Impurities <strong>in</strong> New Drug ProductsAttachment 2: Illustration of Report<strong>in</strong>g Degradation Product Resultsfor Identification and Qualification <strong>in</strong> an ApplicationThe attachment is only illustrative and is not <strong>in</strong>tended to serve as a template howresults on degradation <strong>products</strong> should be presented <strong>in</strong> an application file. Normallyraw data are not provided.Example 1: 50 mg Maximum Daily DoseReport<strong>in</strong>g threshold: 0.1%Identification threshold: 0.2%Qualification threshold: 200 µg'Raw' Result(%)ReportedResult(%)(Report<strong>in</strong>gThreshold =0.1%)Total DailyIntake (TDI)of theDegradationProduct(roundedresult <strong>in</strong> 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 DoseReport<strong>in</strong>g threshold: 0.05%Identification threshold: 2 mgQualification threshold: 3 mg'Raw' Result(%)ReportedResult(%)(Report<strong>in</strong>gThreshold =0.05%)Total DailyIntake (TDI)of theDegradationProduct(roundedresult <strong>in</strong> 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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