Assay (Acidim.).....................................................................85,0-100,5 %
Identity according to Pharmacopoeias................................................ p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Residual solvents (Ph.Eur./USP)............................................................ p/t
Carbonate (as K2CO3)....................................................................... 1,0 %
Chloride (Cl).................................................................................. 0,005 %
Phosphate (PO4)........................................................................... 0,002 %
Sulphate (SO4).............................................................................. 0,005 %
Heavy metals (as Pb).................................................................... 0,001 %
Al.................................................................................................. 0,002 %
As............................................................................................... 0,0001 %
Ca................................................................................................. 0,005 %
Fe.................................................................................................. 0,001 %
Mg................................................................................................ 0,005 %
Na..................................................................................................... 1,0 %
Pb................................................................................................. 0,001 %
Residual metals ICP:
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
