Diluted Acetic Acid
DEFINITION
Diluted Acetic Acid is a solution containing, in each 100 mL, NLT 5.7 g and NMT 6.3 g of acetic acid (C2H4O2).
Prepare Diluted Acetic Acid as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795).| Acetic Acid | 158 mL |
| Purified Water, a sufficient quantity to make | 1000 mL |
Mix the ingredients.
IDENTIFICATION
• A. Identification Tests—General, Acetate 191:
Meets the requirements
191:
Meets the requirements
ASSAY
• Procedure
Sample:
25 mL
Analysis:
To the Sample add 15 mL of carbon dioxide-free water. Add phenolphthalein TS, and titrate with 1 N sodium hydroxide VS. Each mL of 1 N sodium hydroxide is equivalent to 60.05 mg of acetic acid (C2H4O2).
Acceptance criteria:
5.7–6.3 g of acetic acid per 100 mL of Diluted Acetic Acid
IMPURITIES
• Heavy Metals, Method I 231
231
Test preparation:
Evaporate 5 mL in a porcelain dish on a steam bath to dryness. Warm the residue with 2 mL of 1 N acetic acid, and dilute with water to 50 mL. Dilute 20 mL of this solution with water to 25 mL.
Acceptance criteria:
NMT 10 ppm
• Limit of Chloride
Sample solution:
A solution of Diluted Acetic Acid in water (6 in 10)
Analysis:
Add 5 drops of silver nitrate TS to 10 mL of the Sample solution.
Acceptance criteria:
No opalescence is found.
• Limit of Sulfate
Sample solution:
A solution of Diluted Acetic Acid in water (6 in 10)
Analysis:
Add 5 drops of barium chloride TS to 10 mL of the Sample solution.
Acceptance criteria:
No turbidity is produced.
• Limit of Nonvolatile Residue
Sample:
20 mL
Analysis:
Evaporate the Sample in a tared porcelain dish on a steam bath, and dry it at 105
for 1 h.
for 1 h.
Acceptance criteria:
The weight of the residue does not exceed 1.0 mg (NMT 0.005%).
SPECIFIC TESTS
• Readily Oxidizable Substances
Sample:
20 mL in a glass-stoppered flask
Analysis:
Add 0.30 mL of 0.10 N potassium permanganate to the Sample.
Acceptance criteria:
The pink color is not changed to brown immediately, and the liquid does not become entirely brown or free from a pink tint in less than 30 s.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
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 |
USP35–NF30 Page 1681
Pharmacopeial Forum: Volume No. 27(4) Page 2788