Assay (Acidim.)......................................................................99,0-107,4%
Identity according to Pharmacopoeias................................................ p/t.
Density at 25/25..................................................................... 1,120-1,128
Refractive index n 20/D............................................................ 1,482-1,485
MAX. IMPURITIES
Residue on ignition (as SO4)........................................................... 0,05 %
Total bases........................................................................................... p/t.
Residual solvents (Ph.Eur./USP)............................................................ p/t
Related substances.............................................................................. p/t.
Water (H2O)..................................................................................... 0,15 %
Heavy metals (as Pb).................................................................. 0,0005 %
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
