C15H20N2O4S 324.40

Benzenesulfonamide, 4-acetyl-N-[[cyclohexylamino]carbonyl]-.
1-[(p-Acetylphenyl)sulfonyl]-3-cyclohexylurea [968-81-0].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Acetohexamide RS.

Identification—

Melting range 741: between 182.5 and 187.

Loss on drying 731— Dry it at 105 for 3 hours: it loses not more than 1.0% of its weight.

Residue on ignition 281: not more than 0.1%.

Selenium 291: 0.003%, a 200-mg specimen mixed with 200 mg of magnesium oxide being used.

Heavy metals, Method II 231: 0.002%.

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

Residual solvents 467: meets the requirements.

Assay— Dissolve about 300 mg of Acetohexamide, accurately weighed, in 40 mL of dimethylformamide, add 5 drops of thymol blue TS, and titrate, using a magnetic stirrer, with 0.1 N sodium methoxide VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N sodium methoxide is equivalent to 32.44 mg of C15H20N2O4S.

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

USP29–NF24 Page 48

Phone Number : 1-301-816-8251