Assay calc. a.d.s..................................................................99,0-100,5 %
Identity according to Pharmacopoeias................................................ p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in H2O................................................................... 0,01 %
Loss on drying at 105°C................................................................... 1,0 %
Alkalinity............................................................................................... p/t.
Residual solvents (Ph.Eur./USP)............................................................ p/t
Chloride and bromide (as Cl).......................................................... 0,05 %
Nitrate, nitrite and ammonia................................................................. p/t.
Sulphate (SO4).............................................................................. 0,015 %
Thiosulphate......................................................................................... p/t.
Iodate................................................................................................... p/t.
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0002 %
Ba......................................................................................................... p/t.
Fe.................................................................................................. 0,002 %
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
