Sulfaquinoxaline Oral Solution
»Sulfaquinoxaline Oral Solution contains the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled concentration of sulfaquinoxaline (C14H12N4O2S).
Packaging and storage— Preserve in tight,light-resistant containers.
Labeling— Label it to indicate that it is for veterinary use only.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: not less than 12.
Assay—
Mobile phase and Chromatographic system—Proceed as directed in the Assayunder Sulfaquinoxaline.
Standard preparation— Dissolve an accurately weighed quantity of USP Sulfaquinoxaline RSin 0.01Nsodium hydroxide to obtain a solution having a known concentration of about 0.7mg per mL.Dilute an accurately measured volume of this solution quantitatively with water to obtain a solution having a known concentration of about 0.15mg per mL.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 300mg of sulfaquinoxaline,to a 2000-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Separately inject equal volumes (about 8µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of sulfaquinoxaline (C14H12N4O2S)in each mLof the Oral Solution taken by the formula:
2000(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Sulfaquinoxaline RSin the Standard preparation,Vis the volume,in mL,of Oral Solution taken to prepare the Assay preparation,and rUand rSare the sulfaquinoxaline peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1833
Phone Number:1-301-816-8178