Assay (Acidim.)......................................................................99,5-100,5%

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

Freezing point................................................................................≥15,6°C

MAX. IMPURITIES

Appearance of the substance.............................................................. p/t.

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

Non-volatile matter....................................................................... 0,005 %

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

Easily oxidable substances.................................................................. p/t.

Reducing substances........................................................................... p/t.

Aldehydes (as CH3CHO)................................................................. 0,05 %

Chloride (Cl).................................................................................. 0,001 %

Sulphate (SO4).............................................................................. 0,001 %

Heavy metals (as Pb).................................................................. 0,0005 %

As............................................................................................... 0,0001 %

Fe................................................................................................ 0,0005 %

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