C4H7NaO2 110.10
Butyric acid, sodium salt.
Sodium butyrate [156-54-7].

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.

Identification—

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%.

Organic volatile impurities, Method I 467: meets the requirements.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine

USP29–NF24 Page 1974

Phone Number : 1-301-816-8251