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Furosemide or Frusemide

CAS No.: 54-31-9
Molecular Weight: 330.74 g/mol
Chemical Formula C12H11ClN2O5S

Furosemide or Frusemide is an odorless white to slightly yellow crystalline powder. It is used as a diuretic drug. It is almost tasteless.

General Properties and Specifications of Furosemide or Frusemide or 4-chloro-2-((furan-2-ylmethyl)amino)-5-sulfamoylbenzoic acid:
Appearance: Off - white powder.
Odor: Odorless
Solubility of 1% solution in acetone: Clear.
Assay: 98.5% minimum.
Melting Point: 210C to 220C literature.
Boiling Point: 582C predicted.
Loss on drying: 0.5% maximum.
Solubility: Very slightly soluble in water.
Storage: Room temperature. Preferably refrigerate.


Furosemide USP Grade Specifications:
C12H11ClN2O5S -- 330.74
Benzoic acid, 5-(aminosulfonyl)-4-chloro-2-[(2-furanylmethyl)amino]-;
4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid CAS 54-31-9
UNII: 7LXU5N7ZO5

DEFINITION
Furosemide contains NLT 98.0% and NMT 102.0 of furosemide (C12H11ClN2O5S), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
C. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test by Chromatography.
Loss on Drying: NMT 1.0% at 105C for 3 h.


Furosemide BP Ph Eur Grade Specifications:
C12H11ClN2O5S --- 330.7 CAS54-31-9
Action and use: Loop diuretic.

DEFINITION
4-Chloro-2-[(furan-2-ylmethyl)amino]-5-sulfamoylbenzoic acid.
Content: 98.5 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Practically insoluble in water, soluble in acetone, sparingly soluble in ethanol (96 per cent), practically insoluble in methylene chloride. It dissolves in dilute solutions of alkali hydroxides.

IDENTIFICATION
First identification: B
Second identification: A, C
A. Ultraviolet and visible absorption spectrophotometry.
B. Infrared absorption spectrophotometry.
C. Dissolve about 25 mg in 10 mL of ethanol (96 per cent). Mix 5 mL of the solution and 10 mL of water. To 0.2 mL of this solution add 10 mL of dilute hydrochloric acid and heat under a reflux condenser for 15 min. Allow to cool and add 18 mL of 1 M sodium hydroxide and 1 mL of a 5& g/L solution of sodium nitrite. Allow to stand for 3 min, add 2 mL of a 25 g/L solution of sulfamic acid and mix. Add 1 mL of a 5 g/L solution of naphthyl ethylenediamine dihydrochloride. A violet-red colour develops.

Appearance of solution: The solution is clear and not more intensely coloured than reference solution.
Related substances: To pass the test by chromatograph.
Chlorides: Maximum 200 ppm.
Sulfates: Maximum 300 ppm.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.

For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.