Furazolidone Test Method Data
TEST METHOD of Furazolidone
Identification of Furazolidone
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of furazolidone (RS 164).
B. Dissolve 1 mg in 1 ml of dimethylformamide and add 0.05 ml of 1M ethanolic potassium hydroxide. A deep blue colour is produced.
Acidity or alkalinity
Shake 1 g for 15 minutes with 100 ml of carbon dioxide-free water and filter. The pH of the filtrate is 4.5 to 7.0, Appendix V L.
Furazolidone should be protected from light.
Action and use
Antibacterial; antifungal; antiprotozoal.
Furazolidone is 3-(5-nitrofurfurylideneamino)oxazolidin-2-one. It contains not less than 97.0% and not more than 103.0% of C8H7N3O5, calculated with reference to the dried substance.
Not more than 0.1%, Appendix IX A.
Characteristics of Furazolidone
A yellow, crystalline powder; odourless or almost odourless.
Very slightly soluble in water and in ethanol (96%); slightly soluble in chloroform; practically insoluble in ether .
Carry out in subdued light the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and a mixture of 95 volumes of toluene and 5 volumes of 1,4-dioxan as the mobile phase. Apply separately to the plate 20 µl of solution (1) and 10 µl of solution (2). For solution (1) dissolve 50 mg of the substance being examined in 5 ml ofdimethylformamide by heating on a water bath for a few minutes, allow to cool and dilute to 10 ml with acetone. Solution (2) contains 0.010% w/v solution of nitrofurfural diacetate BPCRS in a mixture of equal volumes of dimethylformamide andacetone. After removal of the plate, heat it at 105 for 5 minutes and spray with a solution prepared by dissolving 0.75 g ofphenylhydrazine hydrochloride in 10 ml of ethanol (96%), diluting to 50 ml with water , adding activated charcoal , filtering and then adding 25 ml of hydrochloric acid and sufficient water to produce 200 ml. Any spot corresponding to nitrofurfural diacetate in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2).
Loss on drying
When dried to constant weight at 105, loses not more than 0.5% of its weight. Use 1 g.