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1.03963 SAFC

Iron(II) sulfate heptahydrate

cryst., EMPROVE® ESSENTIAL Ph Eur,BP,USP,FCC

Synonym: Iron vitriol, Iron(II) sulfate heptahydrate

  • CAS Number 7782-63-0

  • Empirical Formula (Hill Notation) FeO4S · 7H2O

  • Molecular Weight 278.01

  •  MDL number MFCD00149719

  •  EC Index Number 231-753-5

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Manufacturing, Biopharmaceutical Process Development and Manufacturing, Cell Culture Ingredients and Supplements for Biopharmaceutical Manufacturing, Excipients,
Agency/Method   BP
  Ph. Eur.
  USP
Quality Level   500
reg. compliance   FCC
product line   Emprove® Essential
potency   319 mg/kg LD50, oral (Rat)
pH   3-4 (20 °C, 50 g/L in H2O)
mp   >60 °C (Elimination of water of crystallisation)
density   1.89 g/cm3 at 20 °C
bulk density   600 kg/m3
InChI   1S/Fe.H2O4S.7H2O/c;1-5(2,3)4;;;;;;;/h;(H2,1,2,3,4);7*1H2/q+2;;;;;;;;/p-2
InChI key   SURQXAFEQWPFPV-UHFFFAOYSA-L
storage conditions   Store at +15°C to +25°C.

Description

Analysis Note

Assay (manganometric): 99.5 - 102.0 %
Identity: passes test
Appearance of solution: passes test
pH-value (5 %; water): 3.0 - 4.0
Chloride (Cl): ≤ 0.01 %
Al (Aluminium): ≤ 0.01 %
As (Arsenic): ≤ 0.0002 %
Co (Cobalt) (*): ≤ 0.002 %
Cr (Chromium): ≤ 0.0050 %
Cu (Copper): ≤ 0.0050 %
Fe III (Iron III): ≤ 0.3 %
Hg (Mercury): ≤ 0.0001 %
Mn (Manganese): ≤ 0.1 %
Ni (Nickel) (*): ≤ 0.0050 %
Pb (Lead): ≤ 0.0002 %
Zn (Zinc): ≤ 0.0025 %
Residual solvents (ICH Q3C): excluded by manufacturing 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, FCC

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