» Sodium Butyrate contains not less than 98.0 percent and not more than 101.0 percent of C4H7NaO2, calculated on the anhydrous basis.
Packaging and storage Preserve in tight containers, and store at controlled room temperature.
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.
A: Infrared Absorption 197K, 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, Method I 921: not more than 1.0%.
Heavy metals, Method II 231: 0.001%.
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 titrate 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.
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USP32NF27 Page 3568Pharmacopeial Forum: Volume No. 28(6) Page 1868