Identity according to Pharmacopoeias:: passes test pH of 5% solution: 4.5-7.5 Freezing point: 55-62°C Viscosity at 99°C: 470-900 cSt Viscosity of 50% w/w sol. kinematic 20°C: 240-472 cSt Viscosity of 50% w/w sol. dynamic 20°C: 260-510 mPa.s Average molecular weight: 7000-9000
Maximum limit of impurities Appearance of solution: passes test Acidity or alkalinity: passes test Insoluble matter in in H2O: passes test Reducing substances: passes test Residue on ignition (as SO4): 0.1 % Hydroxyl value: 12-16 Residual solvents (Ph.Eur/USP): passes test 1,4-Dioxan (G.C.): 0.001% Formaldehyde (CH2O): 0.0015% Ethylene Oxide (G.C.): 0.0001% Water (H2O): 1 % Heavy metals (as Pb): 0.0005% As: 0,0003 % Elemental impurities according to ICH Q3D guide: No metal catalysts are used in the manufacturing process.Class 1-3 elements are not likely to be present above the limits of ICH Q3D option 1.