Acetic Acid Irrigation
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 262.5 mg of C2H4O2.
• A. Identification TestsGeneral, 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.
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: 237.5262.5 mg of C2H4O2 in each 100 mL of Acetic Acid Irrigation
• pH 791: 2.83.4
• Bacterial Endotoxins Test 85: It contains NMT 0.5 USP Endotoxin Unit/mL.
• Other Requirements: It meets the requirements under Injections 1, except that the container in which it is packaged may be designed to empty rapidly and may exceed 1000 mL in capacity.
• 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.
• USP Reference Standards 11
USP Endotoxin RS
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USP35NF30 Page 2065Pharmacopeial Forum: Volume No. 27(3) Page 2501