Packaging and storage— Preserve in tight containers.

Identification— Heat a few drops with about 500 mg of potassium bisulfate in a test tube: pungent vapors of acrolein are evolved.

pH 791: between 5.5 and 7.5.

Residual solvents 467: meets the requirements.

Assay— Transfer an accurately measured volume of Oral Solution, equivalent to about 3 g of glycerin, to a 500-mL volumetric flask, dilute with water to volume, and mix. Transfer a 3-mL portion to a conical flask, add 100.0 mL of a solution of potassium periodate (prepared by dissolving 3 g of potassium periodate in about 500 mL of warm water, cooling to room temperature, and then diluting with water to 1000 mL), swirl, and allow to stand at room temperature for 10 minutes. Add 4 g of sodium bicarbonate and 2 g of potassium iodide, and titrate immediately with 0.1 N potassium arsenite VS, adding 3 mL of starch TS as the endpoint is approached. Perform a blank determination, using water in place of the Oral Solution, and note the difference in volumes required. Each mL of 0.1 N potassium arsenite is equivalent to 2.303 mg of glycerin (C3H8O3).

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

USP29–NF24 Page 1013

Phone Number : 1-301-816-8251