Assay (Acidim.).....................................................................98,0-100,5 %

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

Density at 20/20..................................................................... 1,043-1,049

Refractive index n 20/D........................................................... 1,539-1,541

MAX. IMPURITIES

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

Clarity of solution................................................................................. p/t.

Colour of solution................................................................................. p/t.

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

Non-volatile matter......................................................................... 0,05 %

Residue on ignition (as SO4)......................................................... 0,005 %

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

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

Halogenated compounds and halides (as Cl)................................ 0,03 %

Peroxide value..........................................................................................5

Related substances.......................................................................... (G.C.)

Ciclohexylmethanol........................................................................ 0,10 %

Total imp. Tr < Benzyl Alcohol........................................................ 0,04 %

Total imp. Tr > Benzyl Alcohol.......................................................... 0,3 %

Water (H2O)....................................................................................... 0,2 %

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

Bottled under nitrogen atmosphere.