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M: 110,11 EC: 204-617-8 NC: 2907 22 00
IATA: 9/III PAX: 911 CAO: 911
Signal Word: Danger
H302-H351-H318-H317-H341-H400
Assay (calc. a.d.s.).................................................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
Melting range............................................................................ 172-174°C
MAX. IMPURITIES
Insoluble matter in H2O......................................................................... p/t.
Residue on ignition (as SO4)............................................................. 0,1 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Pyrocatechol.................................................................................. 0,05 %
Sulphate (SO4)................................................................................ 0,05 %
Water (H2O)....................................................................................... 0,5 %
Heavy metals (as Pb).................................................................... 0,002 %
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
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