Assay (Acidim.) calc. a.d.s....................................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
Melting range............................................................................ 168-172°C
pH of 5% solution...................................................................... 10,0-11,5
Related substance (T.L.C).................................................................... p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in H2O................................................................. 0,025 %
Loss on drying at 105°C................................................................... 0,5 %
Residue on ignition (as SO4)............................................................. 0,1 %
Chloride (Cl).................................................................................. 0,003 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Methanol........................................................................................... 0,5 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0001 %
Fe.................................................................................................. 0,001 %
