Assay (G.C.) v/v......................................................................96,0-96,6 %

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

Density at 20/20................................................................. 0,8051-0,8124

MAX. IMPURITIES

Appearance.......................................................................................... p/t.

Colour of solution (USP)....................................................................... p/t.

Clarity of solution (USP)....................................................................... p/t.

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

Volatile impurities (G.C.)....................................................................... p/t.

Non-volatile matter (w/v)............................................................ 0,0025 %

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

Acetone (G.C.).............................................................................. 0,005 %

Acetone, 2-Propanol and 2-Methyl-2-Propanol................................... p/t.

Benzene (UV).............................................................................. 0,0002 %

Butanone (G.C.).............................................................................. 0,02 %

Methanol (G.C.).............................................................................. 0,02 %

2-Propanol (G.C.)........................................................................... 0,03 %

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

1-Pentanol, non-volatile subst. and carbonized subst. by H2SO4........ p/t.

Absorbance.......................................................................................... p/t.

Acidity.................................................................................... 0,002 meq/g

Alkalinity................................................................................ 0,001 meq/g

Acidity and alkalinity............................................................................. p/t.

Fusel oil................................................................................................ p/t.

Aldehydes (as CH3CHO)............................................................... 0,001 %

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

Cu............................................................................................. 0,00002 %

Fe.............................................................................................. 0,00005 %

Ni.............................................................................................. 0,00002 %

Pb............................................................................................. 0,00002 %