Nitrofurazone
;)
Hydrazinecarboxamide,2-[(5-nitro-2-furanyl)methylene]-.
5-Nitro-2-furaldehyde semicarbazone [59-87-0].
»Nitrofurazone,dried at 105
for 1hour,contains not less than 98.0percent and not more than 102.0percent of C6H6N4O4.
for 1hour,contains not less than 98.0percent and not more than 102.0percent of C6H6N4O4.
NOTE—Avoid exposing solutions of nitrofurazone at all times to direct sunlight,excessive heat,strong fluorescent lighting,and alkaline materials.
Packaging and storage—
Preserve in tight,light-resistant containers,and avoid exposure to direct sunlight and to excessive heat.
USP Reference standards á11ñ—
USP Nitrofurazone RS.USP Nitrofurazone Related Compound A RS.
Identification—
A:Infrared Absorption á197Kñ.
B:Ultraviolet Absorption á197Uñ—
Solution:
8µg per mL,prepared as directed in the Assay.
Ratio:
A306/A375does not exceed 0.25.
C:
Dissolve 400mg of potassium hydroxide in 10mLof alcohol.Immediately before use dilute this solution with dimethylformamide to 100mL.To 10mLof the prepared solution add a few crystals of Nitrofurazone:a purple solution results.
pHá791ñ—
Suspend 1g in 100mLof water,shake for 15minutes,allow the suspension to settle,and filter:the pHof the filtrate is between 5.0and 7.5.
Loss on drying á731ñ—
Dry it at 105for 1hour:it loses not more than 0.5%of its weight.
for 1hour:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
Test solution:
dimethylformamide.
Standard solution:
dimethylformamide.
Application volume:
10µL.
Eluant:
a mixture of chloroform,methanol,and ammonium hydroxide (60:24:3),in a nonequilibrated chamber.
Visualization:
1.
Limit of 5-nitro-2-furfuraldazine—
Adsorbent:
0.5-mm layer of chromatographic silica gel.
Test solution—
Transfer 2.0g to a 100-mLvolumetric flask.Dissolve in 60mLof dimethylformamide,dilute with acetone to volume,and mix.
Standard solution—
Transfer 50.0mg of USP Nitrofurazone Related Compound A RSto a 100-mLvolumetric flask,dissolve in and dilute with dimethylformamide to volume,and mix.[NOTE—USP Nitrofurazone Related Compound A RSis 5-nitro-2-furfuraldazine.]Transfer 5.0mLof this solution to a 25-mLvolumetric flask,add 10mLof dimethylformamide,dilute with acetone to volume,and mix.
Application volume:
5µL.
Developing solvent system:
a mixture of ethyl acetate and cyclohexane (4:1).
Procedure—
Proceed as directed for Thin-Layer Chromatography under Chromatography á621ñ.With a suitable densitometer,equipped with a filter having its maximum transmittance at about 254nm,locate and scan the spot produced by the Standard solution and any spot from the Test solution having the same RFas that produced by the Standard solution:the area and intensity of any spot from the Test solutionare not greater than the area and intensity produced by the spot from the Standard solution(0.5%).
Assay—
Transfer about 100mg of Nitrofurazone,previously dried and accurately weighed,to a 250-mLvolumetric flask,dissolve in 50mLof dimethylformamide,dilute with water to volume,and mix.Transfer 5.0mLof this solution to a 250-mLvolumetric flask,dilute with water to volume,and mix.Concomitantly determine the absorbances of this solution and a Standard solution of USP Nitrofurazone RSin the same medium having a known concentration of about 8µg per mL,in 1-cm cells at the wavelength of maximum absorbance at about 375nm,with a suitable spectrophotometer,using water as the blank.Calculate the quantity,in mg,of C6H6N4O4in the Nitrofurazone taken by the formula:
12.5C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Nitrofurazone RSin the Standard solution,and AUand ASare the absorbances of the solution of Nitrofurazone and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1383
Pharmacopeial Forum:Volume No.29(6)Page 1938
Phone Number:1-301-816-8394