Assay (Iodom.).......................................................................99,0-100,5%

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

Specific rotation [a]20/D c=10 (in H2O)................................+20,5 to+21,5°

MAX. IMPURITIES

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

Insoluble matter in H2O......................................................................... p/t.

Residue on ignition (as SO4)............................................................. 0,1 %

Oxalic acid........................................................................................ 0,2 %

Residual solvents (Ph.Eur./USP)........................................................... p/t.

Chloride (Cl).................................................................................. 0,025 %

Sulphate (SO4)................................................................................ 0,01 %

Related substances:

D-Sorbosonic Acid........................................................................... 0,1 %

Methyl-D-Sorbosonate .................................................................. 0,15 %

Other impurities.............................................................................. 0,10 %

Total impurities................................................................................. 0,2 %

Heavy metals (as Pb).................................................................... 0,001 %

Cu............................................................................................... 0,0005 %

Fe................................................................................................ 0,0002 %