Minimum assay (G.C.).................................................................... 99,5 %

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

Density at 20/20..................................................................... 0,790-0,793

Density at 25/25............................................................................. ±0,789

MAX. IMPURITIES

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

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

Non-volatile matter....................................................................... 0,004 %

Related substances.............................................................................. p/t.

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

Ethanol (G.C.).............................................................................. 500 ppm

Benzene (G.C.).......................................................... ......................2 ppm

Reducing substances to KMnO4.......................................................... p/t.

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

Alkalinity............................................................................................... p/t.

Water (H2O)....................................................................................... 0,3 %

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