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M: 97,94 EC: 235-183-8 NC: 2827 59 00
:
Assay (Arg.) calc. a.d.s............................................................99-100,5 %
Identity according to Pharmacopoeias................................................ p/t.
pH of 5% solution.......................................................................... 4,5-6,0
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Insoluble matter in H2O................................................................... 0,01 %
Loss on drying at 105°C................................................................... 0,5 %
Residue on ignition (as SO4)............................................................. 0,1 %
Residual solvents (Ph.Eur.) (*)
Acidity and alkalinity............................................................................. p/t.
Magnesium and alkaline-earth salts (as Ca).................................. 0,02 %
Bromate................................................................................................ p/t.
Chloride (Cl)...................................................................................... 0,5 %
Sulphate (SO4)................................................................................ 0,01 %
Iodide (I)................................................................................................ p/t.
Heavy metals (as Pb).................................................................... 0,001 %
Ba................................................................................................... 0,01 %
Ca................................................................................................... 0,01 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,001 %
Ni.................................................................................................. 0,001 %
Pb................................................................................................. 0,001 %
(*) Excluded by manufacturing process
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