Assay (HPLC) calc. a.d.s.......................................................98,0-101,0%
Assay (Iodom.) calc. a.d.s....................................................98,0-101,0 %
Identity according to Pharmacopoeias................................................ p/t.
Melting range............................................................................ 258-263°C
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Colour of solution................................................................................. p/t.
Insoluble matter in C2H5OH.................................................................. p/t.
Acidity or alkalinity............................................................................... p/t.
Loss on drying at 105°C................................................................... 0,5 %
Residue on ignition (as SO4)............................................................. 0,1 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Cromatography impurities (HPLC)....................................................... p/t.
Related substances (T.L.C.).............................................................. 0,5 %
Fluorane................................................................................................ p/t.
Chloride (Cl).................................................................................... 0,01 %
Sulphate (SO4)................................................................................ 0,02 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0002 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................... 0,01 %
Ni.................................................................................................. 0,001 %
Pb................................................................................................. 0,001 %
