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

Assay (in Cl) (Arg.)..................................................................16,5-17,1 %

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

T.L.C..................................................................................................... p/t.

Specific Rotation [a]20/D c=8

(in HCl 6 mol/l) calc. a.d.s..................................................+21,4 to+23,5°

MAX. IMPURITIES

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

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

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

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

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

Sulphate (SO4)................................................................................ 0,03 %

Ammonium (NH4)............................................................................ 0,02 %

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

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

Fe.................................................................................................. 0,001 %

Residual metals ICP:

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