Assay (Acidim.)......................................................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Loss on drying................................................................................ 0,25 %
Sulphur compounds (as SO4)....................................................... 0,015 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Carbonate............................................................................................. p/t.
Chloride (Cl).................................................................................. 0,005 %
Phosphate (PO4)........................................................................... 0,002 %
Sulphate (SO4)................................................................................ 0,01 %
Ammonium (NH4).......................................................................... 0,002 %
Heavy metals (as Pb).................................................................. 0,0005 %
As............................................................................................... 0,0002 %
Ca................................................................................................... 0,01 %
Fe................................................................................................ 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)............................................................................ 300 ppm
