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M: 132,06 EC: 231-987-8 NC: 3105 30 00
Assay (Acidim.)......................................................................96,0-102,0%
Identity according to Pharmacopoeias................................................ p/t.
pH of 1% solution.......................................................................... 7,6-8,2
MAX. IMPURITIES
Insoluble matter in H2O................................................................... 0,01 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Chloride (Cl).................................................................................. 0,005 %
Sulphate (SO4)................................................................................ 0,01 %
Heavy metals (as Pb).................................................................... 0,001 %
As............................................................................................... 0,0003 %
Cu................................................................................................. 0,001 %
Fe.................................................................................................. 0,003 %
Ni.................................................................................................. 0,001 %
Pb................................................................................................. 0,001 %
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