Assay......................................................................................37,0-38,0 %

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

MAX. IMPURITIES

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

Insoluble matter in H2O......................................................................... p/t.

Residue on ignition (as SO4)........................................................... 0,05 %

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

Acidity................................................................................................... p/t.

Methanol (G.C.)(v/v)..................................................................9,0-15,0 %

Chloride (Cl).................................................................................. 0,003 %

Sulphate (SO4).............................................................................. 0,005 %

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

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