Transcription of Q3D(R2) - ICH
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Q3D(R2) - ICH
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE GUIDELINE FOR elemental impurities Q3D(R2) Draft version Endorsed on 25 September Currently under public consultation At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures. This document for public consultation is comprised of extracts of the Q3D(R2) Guideline with the revisions to the Q3D(R1) Guideline: Part 1 - Extract of Appendix 2: Correction of PDEs for Gold, Silver and Nickel Part 2 - Extract of Appendix 3: Correction of Gold monograph Part 3 - Extract of Appendix 3: Correction of Silver monograph Part 4 - New Appendix 5 Q3D(R2) Document History Code History Date Q3D(R2) Endorsement by the Members of the ICH Assembly under Step 2 and release for public consultation.
1 Appendix 2: Established PDEs for Elemental Impurities 2 Table A.2.1: Permitted Daily Exposures for Elemental Impurities 1 Element Class 2 Oral PDE µg/day Parenteral PDE, µg/day Inhalation PDE, µg/day Cd 1 5 2 3 Pb 1 5 5 5 As 1 15 15 2 Hg 1 30 3 1 Co 2A 50 5 3 V 2A 100 10 1 Ni 2A 200 20 65
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