Assay (Perchl. Ac.) calc. a.d.s...............................................99,0-101,0%
Identity according to Pharmacopoeias................................................ p/t.
T.L.C..................................................................................................... p/t.
Specific rotation [ï¡]25/D c=5 (in HCl 1 mol/l)......................... -9,8 to -11,2°
Specific rotation [ï¡]20/D c=5 (in HCl 1 mol/l) calc. a.d.s........ -11,0 to -12,3°
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in HCl................................................................... 0,05 %
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 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,001 %
Ni.................................................................................................. 0,001 %
Pb................................................................................................. 0,001 %
