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M: 182,65 EC: 211-519-9 NC: 2922 41 00
Assay (Perchl. Ac.) calc. a.d.s..............................................98,5-101,0 %
Assay (as Cl) (Arg.).................................................................19,0-19,5 %
Identity according to Pharmacopoeias................................................ p/t.
Specific rotation [a]20/D c=8 (in HCl) calc. a.d.s................+21,0 to +22,5°
Specific rotation [a]25/D c=8 (in HCl) calc. a.d.s................+20,4 to +21,4°
T.L.C..................................................................................................... p/t.
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Loss on drying at 105°C................................................................... 0,4 %
Residue on ignition (as SO4)............................................................. 0,1 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Ammonium (NH4)............................................................................ 0,02 %
Sulphate (SO4)................................................................................ 0,03 %
Heavy metals (as Pb).................................................................... 0,001 %
Fe.................................................................................................. 0,003 %
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