Minimum assay (G.C.).................................................................... 99,5 %
Identity according to Pharmacopoeias................................................ p/t.
Density at 20/20................................................................... 0,785 - 0,789
Density at 25/25..................................................................... 0,783-0,787
Refractive index n20/D............................................................. 1,376-1,378
MAX. IMPURITIES
Appearance.......................................................................................... p/t.
Non-volatile matter....................................................................... 0,002 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Benzene...................................................................................... 0,0002 %
Ethanol (G.C.)................................................................................. 0,05 %
Peroxides.............................................................................................. p/t.
Related substances.......................................................................... 0,3 %
Acidity or alkalinity............................................................................... p/t.
Water (H2O)....................................................................................... 0,5 %
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
