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 Identification tests B and C under Methylcellulose.

Microbial limits 61— Its total aerobic microbial count does not exceed 100 cfu per mL, and it meets the requirements of the test for the absence of Escherichia coli.

Alcohol content, Method II 611: between 3.5% and 6.5% of C2H5OH.

Residual solvents 467: meets the requirements.

Assay— To boiling flask A, as described under Methoxy Determination 431, transfer an accurately measured volume of Oral 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.

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

USP29–NF24 Page 1395

Phone Number : 1-301-816-8320