Acetic Acid Irrigation
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 262.5 mg of C2H4O2.
IDENTIFICATION
• A. Identification Tests—General, Acetate 
191
191
Sample:
100 mL of Acetic Acid Irrigation
Analysis:
Evaporate the Sample to about 10 mL.
Acceptance criteria:
The resulting solution meets the requirements.
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
SPECIFIC TESTS
• pH 791:
2.8–3.4
791:
2.8–3.4
• Bacterial Endotoxins Test 85:
It contains NMT 0.5 USP Endotoxin Unit/mL.
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.
1, except that the container in which it is packaged may be designed to empty rapidly and may exceed 1000 mL in capacity.
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.
• USP Reference Standards 11
11
USP Endotoxin RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Feiwen Mao, M.S.
Senior Scientific Liaison 1-301-816-8320 |
(SM32010) Monographs - Small Molecules 3 |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2065
Pharmacopeial Forum: Volume No. 27(3) Page 2501