Sulfaquinoxaline Oral Solution
» Sulfaquinoxaline Oral Solution contains the equivalent of not less than 90.0 percent and not more than 110.0 percent 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Deliverable volume 698: meets the requirements.
pH 791: not less than 12.
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Sulfaquinoxaline.
Standard preparation— Dissolve an accurately weighed quantity of USP Sulfaquinoxaline RS in 0.01 N sodium hydroxide to obtain a solution having a known concentration of about 0.7 mg per mL. Dilute an accurately measured volume of this solution quantitatively with water to obtain a solution having a known concentration of about 0.15 mg per mL.
Assay preparation— Transfer an accurately measured volume of Oral Solution, equivalent to about 300 mg of sulfaquinoxaline, to a 2000-mL volumetric flask, dilute with water to volume, and mix.
Procedure— Separately inject equal volumes (about 8 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of sulfaquinoxaline (C14H12N4O2S) in each mL of the Oral Solution taken by the formula:
2000(C / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Sulfaquinoxaline RS in the Standard preparation, V is the volume, in mL, of Oral Solution taken to prepare the Assay preparation, and rU and rS are the sulfaquinoxaline peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals
(VET05) Veterinary Drugs 05
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3631
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.