Assay (Perchl. Ac.) calc. a.d.s...............................................98,5-101,0%

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

Melting range (a.d.s.)................................................................ 234-239°C

MAX. IMPURITIES

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

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

Loss on drying.................................................................................. 0,5 %

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

Related substances (HPLC):

Individual impurity.......................................................................... 0,10 %

Total impurities................................................................................. 0,1 %

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

Chromatographic purity....................................................................... p/t.

Acidity................................................................................................... p/t.

Sulphate (SO4)................................................................................ 0,05 %

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

As............................................................................................... 0,0003 %

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

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

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

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