Packaging and storage—
Preserve in tight containers,and store at controlled room temperature.
Identification—
A:
Dilute 5mLwith 10mLof water,and adjust with 1Nsodium hydroxide to a pHof 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.
pHá791ñ:
between 2.0and 4.0,when diluted with an equal volume of water.
Assay—
Transfer an accurately known quantity of Otic Solution,containing about 100mg of glacial acetic acid,to a 250-mLconical flask,and add 5mLof saturated sodium chloride solution and about 40mLof water.Add 3drops of phenolphthalein TS,and titrate with 0.1Nsodium hydroxide VSto a faint pink endpoint.Each mLof 0.1Nsodium hydroxide is equivalent to 6.005mg of C2H4O2.
Auxiliary Information—
Staff Liaison:
Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 43
Pharmacopeial Forum:Volume No.27(3)Page 2501
Phone Number:1-301-816-8389