Assay (Perchl. Ac.) calc. a.d.s...............................................98,5-101,0%
Identity according to Pharmacopoeias................................................ p/t.
T.L.C..................................................................................................... p/t.
Specific rotation [ï¡]25/D c=1 (in H2O).................................. -29,4 to -32,8°
Specific rotation [ï¡]20/D c=1 (in H2O) calc. a.d.s................. -30,0 to -33,0°
pH of 1% solution.......................................................................... 5,5-7,0
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in HCl......................................................................... p/t.
Loss on drying at 105°C................................................................... 0,3 %
Residue on ignition (as SO4)............................................................. 0,1 %
Residual solvents (Ph.Eur./USP)............................................................ p/t
Impurity A and related substances Impurity A..............................0,001%
Total imp. Tr < Tryptophan...............................................................0,01%
Total imp. Tr > Tryptophan...............................................................0,03%
Ammonium (NH4)............................................................................ 0,02 %
Chloride (Cl).................................................................................... 0,02 %
Sulphate (SO4)................................................................................ 0,03 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................. 0,00015 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,001 %
Ni.................................................................................................. 0,001 %
Pb.................................................................................................
