Methylcellulose Ophthalmic Solution
» Methylcellulose Ophthalmic Solution is a sterile solution of Methylcellulose. It contains not less than 85.0 percent and not more than 115.0 percent of the labeled amount of methylcellulose. It may contain suitable antimicrobial, buffering, and stabilizing agents.
Packaging and storage Preserve in tight containers.
A: Heat a few mL of Ophthalmic Solution: the solution becomes cloudy and a flaky precipitate, which redissolves as the solution cools, appears.
B: Pour a few mL of Ophthalmic Solution onto a glass plate, and allow the water to evaporate: a thin, self-sustaining film results.
Sterility 71: meets the requirements.
pH 791: between 6.0 and 7.8.
Assay To boiling flask A, as described under Methoxy Determination 431, pipet a quantity of Ophthalmic Solution, equivalent to 50 mg of methylcellulose. Evaporate on a steam bath to dryness, cool the flask in an ice bath, add the specified amount of hydriodic acid, and proceed as directed under Methoxy Determination 431. Each mL of 0.1 N sodium thiosulfate is equivalent to 1.753 mg of methylcellulose.
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USP32NF27 Page 2940Pharmacopeial Forum: Volume No. 31(3) Page 780