Assay (Acidim.).......................................................................95,0-98,0 %
Identity according to Pharmacopoeias................................................ p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Residue on ignition....................................................................... 0,002 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Reducing substances to KMnO4.......................................................... p/t.
Chloride (Cl).................................................................................. 0,001 %
Nitrate................................................................................................... p/t.
Ammonium (NH4).......................................................................... 0,001 %
Heavy metals (as Pb).................................................................. 0,0005 %
As............................................................................................... 0,0001 %
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
