Assay (Perchl. Ac.) calc. a.d.s...............................................98,5-101,0%

Identity according to Pharmacopoeias................................................ p/t.

pH of 5% solution.......................................................................... 5,9-6,4

MAX. IMPURITIES

Appearance of solution........................................................................ p/t.

Loss on drying at 105°C................................................................... 0,2 %

Residue on ignition (as SO4)............................................................. 0,1 %

Residual solvents (Ph.Eur./USP)............................................................ p/t

Ninhydrin-positive substances......................................................... 0,5 %

Hydrolizable substances...................................................................... p/t.

Chloride (Cl).................................................................................. 0,007 %

Sulphate (SO4)............................................................................ 0,0065 %

Heavy metals (as Pb).................................................................... 0,001 %

As............................................................................................. 0,00015 %

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