Acetic Acid Otic Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Acetic Acid Otic Solution is a solution of Glacial Acetic Acid in a suitable nonaqueous solvent. It contains NLT 85.0% and NMT 130.0% of the labeled amount of C2H4O2.
2 IDENTIFICATION
A.
Sample solution: Dilute 5 mL of Acetic Acid Otic Solution with 10 mL of water.
Analysis: Adjust the Sample solution with 1 N sodium hydroxide to a pH of 7. Add ferric chloride TS.
Acceptance criteria: A deep red color is produced, and it is destroyed by the addition of hydrochloric acid.
B.
Analysis: Warm it with sulfuric acid and alcohol.
Acceptance criteria: Ethyl acetate, recognizable by its characteristic odor, is evolved.
3 ASSAY
Procedure
Sample: A quantity of Acetic Acid Otic Solution containing 100 mg of glacial acetic acid
Analysis: Transfer the Sample to a 250-mL conical flask, and add 5 mL of saturated sodium chloride solution, 40 mL of water, and 3 drops of phenolphthalein TS. 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 acetic acid (C2H4O2).
Acceptance criteria: 85.0%–130.0%
4 SPECIFIC TESTS
pH 〈791〉
Sample solution: Acetic Acid Otic Solution and water (1:1)
Acceptance criteria: 2.0–4.0
5 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight containers, and store at controlled room temperature.
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