Methylcellulose Oral Solution
» Methylcellulose Oral Solution is a flavored solution of Methylcellulose. It contains not less than 85.0 percent and not more than 115.0 percent of the labeled amount of methylcellulose.
Packaging and storage Preserve in tight, light-resistant containers, and avoid exposure to direct sunlight and to excessive heat. Avoid freezing.
A: Heat a few mL of Oral Solution: the solution becomes cloudy and a flaky precipitate, which redissolves as the solution cools, appears.
B: Pour a few mL of Oral Solution onto a glass plate, and allow the water to evaporate: a thin, self-sustaining film results.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 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.
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.
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USP35NF30 Page 3870Pharmacopeial Forum: Volume No. 31(3) Page 780