FINAL INTERNATIONAL ISO/FDIS DRAFT STANDARD 12787 ISO/TC 217 Cosmetics Analytical methods Secretariat: ISIRI Validation criteria for analytical results Voting begins on: 2011-09-22 using chromatographic technigues Voting terminates on: Cosmétiques - Méthodes analytiques - Criteres de validation pour les 2011-11-22 résultats analytiques utilisant des techniques chromatographiques RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEYAREAWAREANDTO PROVIDESUPPORT ING DOCUMENTATION. INADDITIONTOTHEIREVALUATIONAS Reference number BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO- ISO/FDIS 12787:2011(E) LOGICAL, COMMERCIAL AND USER PURPOSES OCCASIONHAVETOBECONSIDEREDINTHE LIGHT OF THEIR POTENTIAL TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE MADE IN @ ISO 2011 by IHS unde from IHS Not for Resale ISO/FDIS 12787:2011(E) Copyright notice This IsO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicable laws of the user's country, neither this isO draft nor any extract from it may be any means, electronic, Requests for permission to reproduce should be addressed to either IsO at the address below or IsO's member body in the country of the requester. IsO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax+41227490947 E-mail [email protected] Web www.iso.org Reproduction may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. @ IsO 2011 - All rights reserved ed without license from IHS Not for Resale ISO/FDIS 12787:2011(E) Contents Page Foreword .iv 1 Scope. 2 Terms and definitions .. 2.1 General .... 2.2 Terms relating to validation criteria for analytical results .... 3 Principle 4 Generalinformation. 4.1 Matrix effect ....... 4.2 Decision tree.. 5 First step - Minimum validation criteria on standard solutions ... 5.1 General ..... 5.2 Estimation of detection and quantification limit in solvent (optional).. 5.3 Analytical conformity... 5.4 Calibration: precision, linearity and accuracy . 6 Second step - Sample screening 6.1 General. 6.2 Sample screening.. 7 Third step Assays.... .8 7.1 General 7.2 Analytes not detected or detected at concentrations less than the LoQ 7.3 Analytes detected at a concentration greater than the LoQ. 8 Summary Annex A (informative) Example of selection of a weighting factor. 12 Annex B (normative) Assays with a target value (simplified approach).. 13 Bibliography Copyright International Organization for Standardizalon ghts reserved ili nse from IHS Not for Resale