Specification 1.06441.1000 Sodium fluoride EMPROVE® API Ph Eur,BP,USP Specification Method Assay (precitatve titration, calculated on 985-1005 % In-house tied substance) Identity passes test In-house ‘Appearance of solution clear and Phur. colouriess ‘Atkalnty (2s NaOH) sot % In-house Acidity (as HF) 02 % usP Chloride (C1 001 % In-house Hexafuorosiicate (SiFs) sot % In-house Sulfate (804 002 % Phur. Heavy metals (as Pb) 50.003 % In-house Fe (ron) 50.005 % In-house Loss on eying (180 °C, 4h) 505 % usP. Residual solvents Excluded by (Ph EurUSPIICH) manufacturing process Elemental impurty specications have been set considering ICH 30 (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q8D option 1 limit, unless specied and indicated ('. conforms to Ph.Eur., BP, USP De. Dimitry Ryvin ‘Responsibelbortary manapw ql conve) ‘This document has been produced electronically and is valid without a signature Merck KGaA, Frankfurter Strate 250, 64293 Darmstadt (Germany): +49 6151 72.0 Page 1 of 1 EMD Millipore Corporation -a subsidiary of Merck KGaA, Darmstadt, Germany 400 Summit Drive, Burlington, MA 01803, USA, Phone +1 (781) 533-6000 {ALS Version tuotsionooonapony "One 20228