Acetic Acid Otic Solution
»Acetic Acid Otic Solution is a solution of Glacial Acetic Acid in a suitable nonaqueous solvent.It contains not less than 85.0percent and not more than 130.0percent of the labeled amount of C2H4O2.
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