Sulfadimethoxine Soluble Powder
» Sulfadimethoxine Soluble Powder contains Sulfadimethoxine Sodium equivalent to 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 it to indicate that it is for veterinary use only.
USP Reference standards 11
USP Sulfadimethoxine RS
Identification— Shake a quantity equivalent to about 1 g 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 precipitate 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.
Minimum fill 755: meets the requirements.
pH 791: between 7.0 and 8.0, in a solution (1 in 20).
Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Sulfadimethoxine.
Assay preparation— Transfer an accurately weighed portion of 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. 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 Powder taken by the formula:
250C(rU / rS)
in which C is the concentration, in mg per mL, of USP Sulfadimethoxine RS in the Standard preparation; and rU and rS are the 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 3621
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.