Assay (Arg.) calc. a.d.s..........................................................96,0-101,0%

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

MAX. IMPURITIES

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

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

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

Residue on ignition (as SO4)............................................................. 0,5 %

Acidity or alkalinity............................................................................... p/t.

Amines and amine salts....................................................................... 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