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

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

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

Specific rotation [a]20/D c=8 (in HCl 6 mol/l)calc. a.d.s......+26,3 to+27,6°

MAX. IMPURITIES

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

Insoluble matter in H2O......................................................................... 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 %

Ammonia (NH4)............................................................................... 0,02 %

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

As............................................................................................. 0,00015 %

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

Residual metals ICP

Class 1A (Pt, Pd)........................................................................... 10 ppm

Class 1B (Ir, Rh, Ru, Os)................................................................ 10 ppm

Class 1C (Mo, Ni, Cr, V)................................................................. 25 ppm

Class 2 (Cu, Mn).......................................................................... 250 ppm

Class 3 (Fe, Zn).......................................................................... 1300 ppm