Packaging and storage— Preserve in collapsible tubes or in tight containers, preferably at controlled room temperature.

Identification— Filter 5 mL of the solution obtained by titration in the Assay. Add 1 mL of ferric chloride TS to the filtrate: a violet color is produced. Add 1 mL of 6 N acetic acid: the violet color does not change. Add 1 mL of 6 N hydrochloric acid: the violet color is discharged. A small amount of white precipitate may appear.

Alcohol content (if present) 611: from 90.0% to 110.0% of the labeled amount of C2H5OH.

Residual solvents 467: meets the requirements.

Assay— To 25 mL of diluted alcohol add 1 drop of phenolphthalein TS and sufficient 0.1 N sodium hydroxide to produce a faint pink color. Add 5.0 g of Gel, accurately weighed, and stir. Titrate the dispersion with 0.1 N sodium hydroxide VS until a pink color is produced. [NOTE—Reserve this solution for the Identification test.] Each mL of 0.1 N sodium hydroxide is equivalent to 13.81 mg of C7H6O3.

Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals

USP29–NF24 Page 1941

Phone Number : 1-301-816-8320