Assay (Acidim.) calc. a.d.s....................................................99,5-100,5%

Identity according to Pharmacopoeias................................................ p/t.

Melting range............................................................................ 121-123°C

MAX. IMPURITIES

Appearance of solution........................................................................ p/t.

Insoluble matter in Cl3CH............................................................... 0,01 %

Insoluble matter in C2H5OH.................................................................. p/t.

Residue on ignition (as SO4)........................................................... 0,05 %

Residual solvents (Ph.Eur./USP)........................................................... p/t.

Reducing substances to KMnO4.......................................................... p/t.

Darkened substances by H2SO4........................................................... p/t.

Water (H2O)....................................................................................... 0,7 %

Halogenated compounds and halides (as Cl)................................ 0,03 %

Sulphate (SO4).............................................................................. 0,005 %

Heavy metals (as Pb).................................................................... 0,001 %

As............................................................................................... 0,0003 %

Cu................................................................................................. 0,001 %

Fe.................................................................................................. 0,001 %

Ni.................................................................................................. 0,001 %

Pb................................................................................................. 0,001 %