Assay (C6H6O)........................................................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
Freezing point (a.d.s.)....................................................................≥39,5°C
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in H2O......................................................................... p/t.
Non-volatile matter......................................................................... 0,05 %
o-Cresol (G.C.).................................................................................. 0,1 %
m-Cresol (G.C.)................................................................................. 0,1 %
p-Cresol (G.C.)................................................................................. 0,1 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Acidity................................................................................................... p/t.
Water (H2O)....................................................................................... 0,5 %
Chloride (Cl).................................................................................. 0,005 %
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
