C2H4O2 60.05

Acetic acid.
Acetic acid [64-19-7].

Packaging and storage— Preserve in tight containers, and store at room temperature.

Identification— A mixture of 1 volume of it with 2 volumes of water responds to the tests for Acetate 191.

Congealing temperature 651: not lower than 15.6.

Limit of nonvolatile residue— Evaporate 20 mL in a tared dish, and dry at 105 for 1 hour: the weight of the residue does not exceed 1.0 mg.

Chloride— Dilute 1.0 mL with 20 mL of water, and add 5 drops of silver nitrate TS: no opalescence is produced.

Sulfate— Dilute 1.0 mL with 10 mL of water, and add 1 mL of barium chloride TS: no turbidity is produced.

Heavy metals 231— To the residue obtained in the test for Limit of nonvolatile residue add 8 mL of 0.1 N hydrochloric acid, warm gently until solution is complete, dilute with water to 100 mL, and use 20 mL of the solution: the limit is 5 ppm.

Readily oxidizable substances— Dilute 2.0 mL in a glass-stoppered vessel with 10 mL of water, and add 0.10 mL of 0.10 N potassium permanganate: the pink color is not changed to brown within 2 hours.

Residual solvents 467: meets the requirements.

Assay— Measure about 2 mL of Glacial Acetic Acid into a glass-stoppered flask, previously tared while containing about 20 mL of water, and weigh again to obtain the weight of the substance under assay. Add 20 mL of water, then 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 C2H4O2.

Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals

USP29–NF24 Page 47

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