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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.
Identification— It responds to Identification tests B and C under Methylcellulose.
Sterility 71: meets the requirements.
pH 791: between 6.0 and 7.8.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 1395
Pharmacopeial Forum : Volume No. 31(3) Page 780
Phone Number : 1-301-816-8320