Assay.....................................................................................99,0-100,5%
Identity according to Pharmacopoeias................................................ p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in H2SO4..................................................................... p/t.
Soluble matter in HCl dil................................................................... 0,5 %
Soluble matter in H2O..................................................................... 0,25 %
Loss on drying at 105°C................................................................... 0,5 %
Loss on ignition at 800°C................................................................. 0,5 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Acidity or alkalinity............................................................................... p/t.
Heavy metals (as Pb).................................................................... 0,002 %
As............................................................................................... 0,0001 %
Ba......................................................................................................... p/t.
Fe.................................................................................................... 0,02 %
Hg............................................................................................... 0,0001 %
Pb................................................................................................. 0,001 %
Sb............................................................................................... 0,0002 %