Assay (Acidim.) calc. a.d.s...................................................99,5-100,5 %
Identity according to Pharmacopoeias................................................ p/t.
Melting range............................................................................ 159-161°C
T.L.C..................................................................................................... p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in C2H5OH.................................................................. p/t.
Loss on drying.................................................................................. 0,5 %
Residue on ignition (as SO4)........................................................... 0,05 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Darkened substances by H2SO4........................................................... p/t.
Related substances (HPLC)............................................................. 0,2 %
Chloride (Cl).................................................................................... 0,01 %
Sulphate (SO4)................................................................................ 0,02 %
Heavy metals (as Pb).................................................................... 0,002 %
Cu............................................................................................... 0,0005 %
Fe................................................................................................ 0,0005 %
Ni................................................................................................ 0,0005 %
Pb............................................................................................... 0,0005 %
