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.
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.
USP35NF30 Page 4711
Pharmacopeial Forum: Volume No. 27(2) Page 2198
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