Assay (Perchl. Ac.) calc. a.d.s...............................................98,5-101,0%
Identity according to Pharmacopoeias................................................ p/t.
T.L.C..................................................................................................... p/t.
Specific rotation [ï¡]20/D c=2 (in H2O) (calc. a.d.s.)............... -33,0 to-34,7°
pH of 1% solution.......................................................................... 5,4-6,0
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in HCl 1 mol/l............................................................. p/t.
Loss on drying at 105°C................................................................... 0,3 %
Residue on ignition (as SO4)............................................................. 0,1 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Chloride (Cl).................................................................................... 0,02 %
Sulphate (SO4)................................................................................ 0,03 %
Ammonium (NH4)............................................................................ 0,02 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................. 0,00015 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,001 %
Ni.................................................................................................. 0,001 %
Pb................................................................................................. 0,001 %
