Sulfadimethoxine Soluble Powder
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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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).
1 Packaging and storage
Preserve in tight, light-resistant containers, and store at controlled room temperature.
2 Labeling
Label it to indicate that it is for veterinary use only.
USP Reference standards 〈11〉—
USP Sulfadimethoxine RS
3 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 Identi fication tests under Sulfadimethoxine.
Minimum fill 〈755〉: meets the requirements.
pH 〈791〉: between 7.0 and 8.0, in a solution (1 in 20).
4 Assay
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.
