Packaging and storage— Preserve in tight containers of glass or plastic, containing not more than 15 mL, protected from light. The container or individual carton is sealed and tamper-proof so that sterility is ensured at time of first use.

USP Reference standards 11— USP Glycerin RS.

Identification— It responds to the Identification test under Glycerin.

Sterility 71: meets the requirements.

pH 791: between 4.5 and 7.5, determined potentiometrically in a solution prepared by the addition of 5 mL of Sodium Chloride Injection to 5 mL of Ophthalmic Solution.

Water, Method I 921: not more than 1.0%.

Residual solvents 467: meets the requirements.

Assay— Transfer an accurately measured volume of Ophthalmic 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 Ophthalmic 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 : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals

USP29–NF24 Page 1012

Phone Number : 1-301-816-8320