Packaging and storage— Preserve in tight,light-resistant containers,and avoid exposure to direct sunlight and to excessive heat.Avoid freezing.

Identification— It responds to Identificationtests Band Cunder Methylcellulose.

Microbial limits á61ñ— Its total aerobic microbial count does not exceed 100cfu per mL,and it meets the requirements of the test for the absence of Escherichia coli.

Alcohol content,Method IIá611ñ: between 3.5%and 6.5%of C2H5OH.

Assay— To boiling flask A,as described under Methoxy Determination á431ñ,transfer an accurately measured volume of Oral 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.

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 1258

Phone Number:1-301-816-8323