Assay (Acidim.) calc. a.d.s....................................................98,0-100,5%
Appearance.......................................................................................... p/t.
Identity according to Pharmacopoeias................................................ p/t.
pH of 5% solution.......................................................................... 4,2-4,5
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Appearance........................................................................................... p/t
Insoluble matter in H2O..................................................................... 0,2 %
Loss on drying at 130°C................................................................... 1,0 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Reducing substances........................................................................... p/t.
Chloride (Cl).................................................................................... 0,02 %
Fluoride (F).................................................................................... 0,001 %
Sulphate (SO4)................................................................................ 0,03 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0001 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,001 %
Ni.................................................................................................. 0,001 %
Pb............................................................................................... 0,0005 %
