Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

Option 2b: Permitted concentration limits of elemental impurities across drug product component materials for a product with a specified daily intake: For this example, consider the same solid oral drug product with a maximum daily intake of 2.5 grams, containing 9 components (1 drug substance and 8 excipients, see Table A.4.1) used in Option 1 and 2a. The drug substance synthesis uses Pd and Ni catalysts, and Pb, As, Cd, Hg, and V are also of concern on the basis of the risk assessment. To use Option 2b, the composition of the drug product and additional knowledge regarding the content of each elemental impurity in the components of the drug product are considered. The following table shows example data on elemental impurities that may be derived from the sources described in Section 5.5: Table A.4.4: Concentrations of Elemental Impurities (µg/g) in the Components Concentration (µg/g) Component Pb As Cd Hg Pd V Ni Drug Substance

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