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Guideline on the specification limits for residues of ...

European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, January 2007 Doc. Ref. CPMP/SWP/QWP/4446/00 corr. COMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP) Draft Guideline ON THE specification limits FOR residues OF METAL CATALYSTS DRAFT AGREED BY THE SAFETY WORKING PARTY June 1998 -November 2000 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION January 2001 END OF CONSULTATION (DEADLINE FOR COMMENTS) July 2001 DISCUSSION IN THE SWP October 2001 June 2002 ADOPTION BY CHMP FOR RE- RELEASE FOR

4.3 Setting Concentration Limits of Metals: Oral and Parenteral Routes . Two options are available when setting limits/defining acceptance criteria for metal residues. Option 1: Per individual metal the concentration limits in parts per million (ppm) stated in Table 1 can be used.

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