Assay (Arg.) calc. a.d.s..........................................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Loss on drying at 105°C................................................................... 0,5 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Acidity and alkalinity............................................................................. p/t.
Nitrogen compounds (as N)......................................................... 0,005 %
Bromide (Br)................................................................................. 0,005 %
Chlorate and nitrate (as NO3).......................................................... 0,01 %
Hexacyanoferrate(II)............................................................................. p/t.
Phosphate (PO4)........................................................................... 0,001 %
Nitrite (NO2)........................................................................................... p/t.
Sulphate (SO4)................................................................................ 0,01 %
Iodide.................................................................................................... p/t.
Calcium, Magnesium and alkaline-earth metals (as Ca).............. 0,005 %
Heavy metals (as Pb).................................................................. 0,0005 %
Al.............................................................................................. 0,00002 %
As............................................................................................... 0,0001 %
Ba......................................................................................................... p/t.
Fe................................................................................................ 0,0002 %
K..................................................................................................... 0,05 %
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
