Packaging and storage—
Preserve in tight containers, and store at controlled room temperature.
Identification—
A:
Dilute 5 mL with 10 mL of water, and adjust with 1 N sodium hydroxide to a pH of about 7. Add
ferric chloride TS: a deep red color is produced, and it is destroyed by the addition of hydrochloric acid.
B:
Warm it with sulfuric acid and alcohol: ethyl acetate, recognizable by its characteristic odor, is evolved.
pH 
791
:
between 2.0 and 4.0, when diluted with an equal volume of water.
Assay—
Transfer an accurately known quantity of Otic Solution, containing about 100 mg of glacial acetic acid, to a 250-mL conical flask, and add 5 mL of saturated sodium chloride solution and about 40 mL of water. Add 3 drops of phenolphthalein TS, and titrate with 0.1 N sodium hydroxide VS to a faint pink endpoint. Each mL of 0.1 N sodium hydroxide is equivalent to 6.005 mg of C2H4O2.
Auxiliary Information—
Staff Liaison :
Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 48
Pharmacopeial Forum : Volume No. 27(3) Page 2501
Phone Number : 1-301-816-8320
