Acetic Acid Irrigation
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Tóm tắt nội dung
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 Irrigation is a sterile solution of Glacial Acetic Acid in Water for Injection. It contains, in each 100 mL, NLT 237.5 mg and NMT 262.5mg of C2H4O2.
2 IDENTIFICATION
A. Identification Tests—General, Acetate〈191〉
Sample: 100 mL of Acetic Acid Irrigation
Analysis: Evaporate the Sample to about 10 mL.
Acceptance criteria: The resulting solution meets the requirements.
3 ASSAY
Procedure
Sample: 50 mL of Acetic Acid Irrigation
Analysis: Pipet the Sample into a 150-mL conical flask, add 2 drops of phenolphthalein TS, and titrate with 0.1 N sodium hydroxide VS. Each mL of 0.1 N sodium hydroxide is equivalent to 6.005 mg of acetic acid (C2H4O2).
Acceptance criteria: 237.5–262.5 mg of C2H4O2 in each 100 mL of Acetic Acid Irrigation
4 SPECIFIC TESTS
pH 〈791〉: 2.8–3.4
Bacterial Endotoxins Test 〈85〉: It contains NMT 0.5 USP Endotoxin Unit/mL.
Other Requirements: It meets the requirements under Injections and Implanted Drug Products 〈1〉, except that the container in which it is packaged may be designed to empty rapidly and may exceed 1000 mL in capacity.
5 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in single-dose containers, preferably of Type I or Type II glass, and store at controlled room temperature. It may be packaged in suitable plastic containers.
