Assay (calc. a.d.s.).................................................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
Melting range............................................................................ 109-111°C
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in H2O................................................................... 0,01 %
Loss on drying.................................................................................. 1,0 %
Residue on ignition (as SO4)........................................................... 0,05 %
Ordinary impurities (T.L.C.)............................................................... 0,5 %
Organic volatile impurities.................................................................... p/t.
Acidity or alkalinity............................................................................... p/t.
Phenol.................................................................................................. p/t.
Pyrocatechol........................................................................................ p/t.
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
