Sodium Butyrate
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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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Sodium Butyrate contains not less than 98.0 percent and not more than 101.0 percent of C4H7NaO2, calculated on the anhydrous basis.
1 Packaging and storage
Preserve in tight containers, and store at controlled room temperature.
2 Labeling
Label it to indicate that it is intended for use in compounding dosage forms for rectal use only.
USP Reference standards 〈11〉—
USP Sodium Butyrate RS
3 Identification
Change to read:
A: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020) , on the undried specimen.
B: A solution (1 in 10) meets the requirements of the tests for Sodium 〈191〉.
Alkalinity—Dissolve 2.0 g in 20 mL of water, and add 1 drop of phenolphthalein TS: if a pink color is produced, it is discharged by 0.50 mL of 0.10 N sulfuric acid.
Water Determination, Method I 〈921〉: not more than 1.0%.
4 Assay
Dissolve about 200 mg of Sodium Butyrate, accurately weighed, in 50 mL of glacial acetic acid. Add 1 drop of crystal violet TS, and fititrate with 0.1 N perchloric acid to a green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 11.01 mg of C4H7NaO2.
