Assay (Acidim.) calc. a.d.s....................................................98,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
pH of 5% solution.......................................................................... 8,5-9,6
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in H2O................................................................... 0,01 %
Loss on drying at 130°C................................................................... 1,0 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Potassium di-Hydrogen Phosphate..................................................... p/t.
Reducing substances to KMnO4.......................................................... p/t.
Chloride (Cl).................................................................................... 0,02 %
Fluoride (F).................................................................................... 0,001 %
Sulphate (SO4)................................................................................ 0,05 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0002 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,001 %
Ni.................................................................................................. 0,001 %
Pb................................................................................................. 0,001 %
