Assay (calc. a.a.s.).................................................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
pH of 5% solution.......................................................................... 5,2-9,2
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Loss on drying at 130°C.........................................................52,0-57,0 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Acidity or Alkalinity............................................................................... p/t.
Chloride (Cl).................................................................................... 0,01 %
Nitrogen compounds (as N)......................................................... 0,003 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0002 %
Ca................................................................................................... 0,01 %
Fe.................................................................................................. 0,002 %
Mg.................................................................................................. 0,01 %
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
