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1.03967 SAFC

Iron(II) sulfate hydrate

(about 87% FeSO₄) extra pure Ph.Eur.,BP,USP

Synonym: Ferrosulfate hydrate, Iron(II) sulfate hydrate

  • CAS Number 13463-43-9

  • Empirical Formula (Hill Notation) FeO4S · xH2O

  • Molecular Weight 151.91 (anhydrous basis)

  •  MDL number MFCD00149722

  •  EC Index Number 231-753-5

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Mineral Salts,
Agency/Method   BP
  Ph. Eur.
  USP
Quality Level   400
potency   319 mg/kg LD50, oral (Rat)
pH   2.5-3.8 (20 °C, 50 g/L in H2O)
mp   300 °C (Elimination of water of crystallisation)
density   2.97 g/cm3
bulk density   850 kg/m3
InChI   1S/Fe.H2O4S.H2O/c;1-5(2,3)4;/h;(H2,1,2,3,4);1H2/q+2;;/p-2
InChI key   XBDUTCVQJHJTQZ-UHFFFAOYSA-L
storage conditions   Store at +15°C to +25°C.

Description

Analysis Note

Assay (manganometric, Fe SO₄): 86.0 - 89.0 %
Identity: passes test
Insoluble matter: ≤ 0.05 %
pH-value (5 %; water): 3.0 - 4.0
Chloride (Cl): ≤ 0.03 %
Iron(III)-salts: ≤ 0.4 %
Heavy metals (as Pb): ≤ 0.005 %
As (Arsenic): ≤ 0.0002 %
Cd (Cadmium)*: ≤ 0.0002
Co (Cobalt)*: ≤ 0.0100 %
Cr (Chromium)*: ≤ 0.0100 %
Cu (Copper): ≤ 0.0025 %
Hg (Mercury): ≤ 0.0003 %
Mn (Manganese): ≤ 0.1 %
Ni (Nickel)*: ≤ 0.0100 %
Pb (Lead)*: ≤ 0.001
V (Vanadium)*: ≤ 0.0100 %
Zn (Zinc): ≤ 0.0025 %
Residual solvents (ICH Q3C): excluded by production process
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph.Eur.,BP,USP

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