SPIFAN SP Meeting September 17, 2016

Examples ISO/IDF input • "MLT protocol will be modified to take into account the possibility of using non USP standard with purity verified by UV" • "There is no regulation for the cis and trans forms and results created by this method would not be comparable with results from the existing CEN standard" • "Tergitol is now to be listed as optional per NL comment. We suspect any surfactant would do as good a job to keep the spray chamber clean" Other examples ISO/IDF input • Use criteria for description of equipment and chemicals (e.g. purity grade, tolerance levels), rather than specifying supplier/manufacturer. • Explicitly describe use of broader range equipment if possible. • Include storage temperature and shelf life of chemicals. • Align equipment need with description in method: e.g. avoid unnecessary precision balances.