Methylcellulose Ophthalmic Solution
»Methylcellulose Ophthalmic Solution is a sterile solution of Methylcellulose.It contains not less than 85.0percent and not more than 115.0percent 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 Identificationtests Band Cunder Methylcellulose.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 6.0and 7.8.
Assay— To boiling flask A,as described under Methoxy Determination á431ñ,pipet a quantity of Ophthalmic Solution,equivalent to 50mg 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 á431ñ.Each mLof 0.1Nsodium thiosulfate is equivalent to 1.753mg of methylcellulose.
Auxiliary Information— Staff Liaison:Justin Lane,B.S.,Scientific Associate
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 1258
Phone Number:1-301-816-8323