Assay (Perchl. Ac.).................................................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
Specific rotation [ï¡]20/D c=10 (in HCl 2 mol/l)....................+24,8 to +25,3°
pH of 5% solution.......................................................................... 6,7-7,2
MAX. IMPURITIES
Clarity and colour of solution............................................................... p/t.
Insoluble matter in H2O................................................................... 0,05 %
Loss on drying at 100°C................................................................... 0,5 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Chloride (Cl)...................................................................................... 0,2 %
Sulphate (SO4)................................................................................ 0,05 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................. 0,00015 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,001 %
Ni.................................................................................................. 0,001 %
Pb................................................................................................. 0,001 %
