Assay (Perchl. Ac.) calc. a.d.s...............................................99,0-101,0%
Identity according to Pharmacopoeias................................................ p/t.
pH of 3% solution.......................................................................... 7,5-9,2
MAX. IMPURITIES
Insoluble matter in H2O................................................................... 0,05 %
Loss on drying at 120°C................................................................... 1,0 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Chloride (Cl).................................................................................. 0,005 %
Sulphate (SO4).............................................................................. 0,005 %
Ammonium (NH4).......................................................................... 0,005 %
Calcium and Magnesium (as Ca)......................................................... p/t.
Heavy metals (as Pb).................................................................... 0,001 %
Al.............................................................................................. 0,00002 %
As............................................................................................. 0,00005 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,001 %
K........................................................................................................... p/t.
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
