Identity according to Pharmacopoeias................................................ p/t.
Density at 25/25......................................................................... 1,06-1,09
Viscosity at 25°C....................................................................300-500 cSt
MAX. IMPURITIES
Total ash......................................................................................... 0,25 %
Composition of fatty acids................................................................... p/t.
Acidity value..........................................................................................2,0
Hydroxyl value.................................................................................. 65-80
Peroxide value.....................................................................................10,0
Saponification value......................................................................... 45-55
Iodine value...................................................................................... 18-24
Reducing impurities.............................................................................. p/t.
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Ethylene Oxide........................................................................... 0,0001 %
Dioxane........................................................................................ 0,001 %
Water (H2O)....................................................................................... 3,0 %
Heavy metals (as Pb).................................................................... 0,001 %
Residual metals ICP: (according to EMEA/CHMP/SWP/4446/2000)
Class 1A (Pt, Pd)........................................................................... 10 ppm
Class 1B (Ir, Rh, Ru, Os)................................................................ 10 ppm
Class 1C (Mo, Ni, Cr, V)................................................................. 25 ppm
Class 2 (Cu, Mn).......................................................................... 250 ppm
Class 3 (Fe, Zn).......................................................................... 1300 ppm
