Assay (Acidim.) calc. a.d.s....................................................99,0-101,0%
Identity according to Pharmacopoeias................................................ p/t.
Melting range................................................................................ 81-83°C
T.L.C..................................................................................................... p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in C2H5OH.................................................................. p/t.
Loss on drying.................................................................................. 1,0 %
Residue on ignition (as SO4)........................................................... 0,05 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Darkened substances by H2SO4........................................................... p/t.
As............................................................................................... 0,0001 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,001 %
Ni.................................................................................................. 0,001 %
Pb................................................................................................. 0,001 %