Assay (Acidim.) calc. a.a.s.....................................................98,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
pH of 5% solution.......................................................................... 4,2-4,5
MAX. IMPURITIES
Appearance and colour of solution...................................................... p/t.
Insoluble matter in H2O................................................................. 0,005 %
Loss on drying at 130°C.........................................................11,5-14,5 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Reducing substances to KMnO4.......................................................... p/t.
Chloride (Cl).................................................................................. 0,014 %
Sulphate (SO4)................................................................................ 0,03 %
Aluminium, Calcium and related elements........................................... p/t.
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0002 %
Fe.................................................................................................. 0,001 %
