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

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

Melting range............................................................................ 128-131°C

MAX. IMPURITIES

Insoluble matter in H2O..................................................................... 0,1 %

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

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

Fumaric Acid.................................................................................... 1,0 %

Maleic Acid..................................................................................... 0,05 %

Chloride (Cl).................................................................................... 0,01 %

Sulphate (SO4)................................................................................ 0,02 %

Heavy metals (as Pb).................................................................... 0,002 %

As............................................................................................... 0,0001 %

Cu................................................................................................. 0,002 %

Fe.................................................................................................. 0,002 %

Ni.................................................................................................. 0,002 %

Pb................................................................................................. 0,002 %