Sulfadimethoxine Tablets
» Sulfadimethoxine Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of sulfadimethoxine (C12H14N4O4S).
Packaging and storage— Preserve in tight, light-resistant containers, and store at controlled room temperature.
Labeling— Label the Tablets to indicate that they are for veterinary use only.
USP Reference standards 11—
USP Sulfadimethoxine RS.
Identification— Shake a quantity of finely powdered Tablets, equivalent to about 1 g of sulfadimethoxine, with 5 mL of diluted hydrochloric acid and 10 mL of water. Filter, and to the filtrate add 2.5 N sodium hydroxide dropwise until a precipitate forms and redissolves. Add diluted hydrochloric acid dropwise until a precipitate forms. Collect the filtrate on a very fine filter, and wash it with water and with ether: the sulfadimethoxine so obtained meets the requirements for the Identification tests under Sulfadimethoxine.
Disintegration 701: 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay—
Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Sulfadimethoxine.
Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 50 mg of sulfadimethoxine, to a 250-mL volumetric flask, add about 200 mL of Mobile phase, and swirl to dissolve. Dilute with Mobile phase to volume, and mix. Filter if necessary to obtain a clear solution. Protect this solution from light.
Procedure— Proceed as directed in the Assay under Sulfadimethoxine. Calculate the quantity, in mg, of sulfadimethoxine (C12H14N4O4S) in the portion of Tablets taken by the formula:
250C(rU / rS)
in which the terms are as defined therein.
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
1-301-816-8178		 (VET05) Veterinary Drugs 05
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106		 (BPC05) Biopharmaceutics05
USP32–NF27 Page 3622
Pharmacopeial Forum: Volume No. 27(2) Page 2198
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.