Assay (Acidim.)......................................................................98,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Residual solvents (Ph.Eur./USP)............................................................ p/t
Carbonate (as Na2CO3)..................................................................... 1,0 %
Nitrogen compounds (as N)......................................................... 0,002 %
Chloride (Cl).................................................................................. 0,005 %
Phosphate (PO4)........................................................................... 0,002 %
Sulphate (SO4).............................................................................. 0,005 %
Heavy metals (as Pb).................................................................... 0,001 %
Fe.................................................................................................. 0,001 %
K........................................................................................................... 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
