Assay (Acidim.) calc. a.d.s....................................................98,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
pH of 5% solution.......................................................................... 8,7-9,4
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in H2O................................................................. 0,025 %
Loss on drying at 105°C................................................................... 1,0 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Sodium di-Hydrogen Phosphate.......................................................... p/t.
Reducing substances to KMnO4.......................................................... p/t.
Nitrogen compounds (as N)......................................................... 0,003 %
Chloride (Cl).................................................................................. 0,005 %
Sulphate (SO4)................................................................................ 0,03 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0001 %
Fe.................................................................................................. 0,002 %
