Identified Degradation Product A degradation product for which a structural

Identified degradation product a degradation product

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Identified Degradation Product : A degradation product for which a structural characterisation has been achieved. Impurity : Any component of the new drug product that is not the drug substance or an excipient in the drug product. Impurity Profile : A description of the identified and unidentified impurities present in a drug product. New Drug Substance : The designated therapeutic moiety that has not been previously registered in a region or member state (also referred to as a new molecular entity or new chemical entity). It can be a complex, simple ester, or salt of a previously approved substance. Qualification : The process of acquiring and evaluating data that establishes the biological safety of an individual degradation product or a given degradation profile at the level(s) specified. Qualification Threshold : A limit above (>) which a degradation product should be qualified. Reporting Threshold : A limit above (>) which a degradation product should be reported. Specified Degradation Product : A degradation product that is individually listed and limited with a specific acceptance criterion in the new drug product specification. A specified degradation product can be either identified or unidentified. Unidentified Degradation Product : A degradation product for which a structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time). Unspecified Degradation Product : A degradation product that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug product specification.
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Impurities in New Drug Products 7 Attachment 1: Thresholds for Degradation Products in New Drug Products Reporting Thresholds Maximum Daily Dose 1 Threshold 2,3 1 g 0.1% > 1 g 0.05% Identification Thresholds Maximum Daily Dose 1 Threshold 2, 3 < 1 mg 1.0% or 5 μg TDI, whichever is lower 1 mg - 10 mg 0.5% or 20 μg TDI, whichever is lower >10 mg - 2 g 0.2% or 2 mg TDI, whichever is lower > 2 g 0.10% Qualification Thresholds Maximum Daily Dose 1 Threshold 2,3 < 10 mg 1.0% or 50 μg TDI, whichever is lower 10 mg - 100 mg 0.5% or 200 μg TDI, whichever is lower >100 mg - 2 g 0.2% or 3 mg TDI, whichever is lower > 2 g 0.15% Notes on Attachment 1 1 The amount of drug substance administered per day 2 Thresholds for degradation products are expressed either as a percentage of the drug substance or as total daily intake (TDI) of the degradation product. Lower thresholds can be appropriate if the degradation product is unusually toxic. 3 Higher thresholds should be scientifically justified.
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