Assay (Perchl. Ac.) calc. a.a.s...............................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
pH of 5% solution.......................................................................... 7,5-9,0
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in H2O................................................................. 0,025 %
Loss on drying at 180°C.............................................................3,0-6,0 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Darkened substances by H2SO4........................................................... p/t.
Acidity or alkalinity............................................................................... p/t.
Water (H2O).................................................................................4,0-7,0 %
Chloride (Cl).................................................................................. 0,005 %
Oxalate (C2O4)................................................................................. 0,03 %
Sulphate (SO4)................................................................................ 0,01 %
Tartrate (C4H4O6).................................................................................... p/t.
Ammonium (NH4).......................................................................... 0,002 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0001 %
Na..................................................................................................... 0,3 %
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
