Sulfadiazine Sodium

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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1 DEFINITION

Sulfadiazine Sodium contains NLT 99.0% and NMT 100.5% of sulfadiazine sodium, calculated on the dried basis.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (USP 1-Dec-2021)

Sample: 1.5 g

Analysis: Dissolve the Sample in 25 mL of water, and add 3 mL of 6 N acetic acid. A white precipitate of sulfadiazine is formed. Collect the precipitate on a filter, wash it well with cold water, and dry at 105° for 1 h.

Acceptance criteria: Meets the requirements

(USP 1-Dec-2021)

B. Identification Tests—General 〈191〉, Sodium

Sample: 500 mg

Analysis: Ignite the Sample and use the residue.

Acceptance criteria: Meets the requirements

Add the following:

C. Melting Range or Temperature 〈741〉

Sample: Use the residue from Identification A.

Acceptance criteria: The melting range of the residue as determined by the method for Class 1a is 250°–254°. (USP 1-Dec-2021)

3 ASSAY

Procedure

Analysis: Proceed as directed in Nitrite Titration 〈451〉. Each milliliter of 0.1 M sodium nitrite is equivalent to 27.23 mg of sulfadiazine sodium.

Acceptance criteria: 99.0%–100.5% on the dried basis

4 IMPURITIES

Delete the following:

Selenium 〈291〉

Sample: 200 mg

Acceptance criteria: NMT 30 ppm (USP 1-Dec-2021)

5 SPECIFIC TESTS

Loss on Drying 〈731〉

Analysis: Dry at 105° for 2 h.

Acceptance criteria: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers. Store at 25°, excursions permitted between 15° and 30°.

USP Reference Standards 〈11〉

USP Sulfadiazine RS