Assay (Acidim.) calc. a.d.s...................................................98,5-101,5 %

Identity according to Pharmacopoeias................................................ p/t.

T.L.C..................................................................................................... p/t.

Specific rotation [a]20/D c=8 (in HCl 7 mol/l) (calc. a.d.s.).......+24,0 to +26,0°

MAX. IMPURITIES

Appearance of solution........................................................................ p/t.

Insoluble matter in HCl 1 mol/l............................................................. p/t.

Loss on drying at 105°C................................................................... 0,5 %

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 %