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1.02787 SAFC

Copper(II) sulfate pentahydrate

cryst. EMPROVE® ESSENTIAL Ph Eur,BP,USP

Synonym: Copper monosulfate pentahydrate, Copper vitriol pentahydrate, Copper(II) sulfate pentahydrate

  • CAS Number 7758-99-8

  • Empirical Formula (Hill Notation) CuO4S · 5H2O

  • Molecular Weight 249.69

  •  MDL number MFCD00149681

  •  EC Index Number 231-847-6

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Mineral Salts, Solid Dosage Forms More...
Agency/Method   BP
  Ph. Eur.
  USP
Quality Level   500
product line   Emprove® Essential
potency   960 mg/kg LD50, oral (Rat)
  >2000 mg/kg LD50, skin (Rat)
pH   3.5-4.5 (20 °C, 50 g/L in H2O)
mp   147 °C
density   2.284 g/cm3 at 20 °C
InChI   1S/Cu.H2O4S.5H2O/c;1-5(2,3)4;;;;;/h;(H2,1,2,3,4);5*1H2/q+2;;;;;;/p-2
InChI key   JZCCFEFSEZPSOG-UHFFFAOYSA-L
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (iodometric): 99.0 - 100.5 %
Assay (iodometric, dried substance): 98.5 - 100.5 %
Identity: passes test
Appearance of solution: passes test
Chloride (Cl): ≤ 0.0100 %
Al (Aluminium): ≤ 0.0005 %
Ca (Calcium): ≤ 0.005 %
Co (Cobat) (*): ≤ 0.00005
Cr (Chromium): ≤ 0.005 %
Fe (Iron): ≤ 0.003 %
K (Potassium): ≤ 0.01 %
Na (Sodium): ≤ 0.02 %
Ni (Nickel) (*): ≤ 0.005 %
Pb (Lead) (*): ≤ 0.0050 %
Zn (Zinc): ≤ 0.03 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Loss on drying (250 °C): 35.0 - 36.5 %
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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