Assay (Acidim.) calc. a.d.s....................................................99,5-100,5%

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

MAX. IMPURITIES

Insoluble matter in H2O................................................................... 0,05 %

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

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

Maleic acid (HPLC)........................................................................... 0,1 %

Chloride (Cl).................................................................................. 0,005 %

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

Water (H2O)....................................................................................... 0,5 %

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

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

Cu................................................................................................. 0,001 %

Fe.................................................................................................. 0,001 %

Ni.................................................................................................. 0,001 %

Pb................................................................................................. 0,001 %