Acetylcholine Chloride

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₇H₁₆ClNO₂ 181.66

Ethanaminium, 2-(acetyloxy)-N,N,N-trimethyl-, chloride;

Choline acetate (ester) chloride CAS RN®: 60-31-1; UNII: AF73293C2R.

1 DEFINITION

Acetylcholine Chloride contains NLT 98.0% and NMT 102.0% of acetylcholine chloride (C H ClNO ), calculated on the dried basis.

2 IDENTIFICATION

 A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

B.

Sample solution: 100 mg/mL in water.

Analysis: To 5 mL of Sample solution add 5 mL of silver nitrate TS.

Acceptance criteria: A white, curdy precipitate, which is soluble in ammonium hydroxide but insoluble in nitric acid, is formed.

2.1 ASSAY

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Procedure

Sample: 400 mg of Acetylcholine Chloride.

Analysis: Dissolve in 15 mL of water in a glass-stoppered conical flask, add 40.0 mL of 0.1 N sodium hydroxide VS, and heat on a steam bath for 30 min. Insert the stopper, allow to cool, add phenolphthalein TS, and titrate the excess alkali with 0.1 N sulfuric acid VS. Perform a blank determination (see Titrimetry 〈541〉 (CN 1-Aug-2024) ). Each mL of 0.1 N sodium hydroxide is equivalent to 18.17 mg of C₇H₁₆ClNO₂.

Acceptance criteria: 98.0%–102.0% on the dried basis

3 OTHER COMPONENTS

Content of Chloride

Sample: 280 mg of Acetylcholine Chloride.

C₇H₁₆ClNO₂ Dissolve the Sample in 140 mL of water, and add 1 mL of dichloro fluorescein TS. Titrate with 0.1 N silver nitrate VS until the silver chloride flocculates and the mixture acquires a faint pink color. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of Cl.

Acceptance criteria: 19.3%–19.8% of Cl on the dried basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.2%

5 SPECIFIC TESTS

Melting Range or Temperature, Class I〈741〉: 149°–152°

Acidity

Sample: 100 mg of Acetylcholine Chloride

Analysis: Dissolve the Sample in 10 mL of recently boiled water, and add at once 1 drop of bromothymol blue TS.

Acceptance criteria: NMT 0.50 mL of 0.010 N sodium hydroxide is required to produce a color change.

Loss on Drying 〈731〉

Analysis: Dry a sample at 105° for 3 h.

Acceptance criteria: NMT 1.0%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in a tight container, and store at controlled room temperature.

USP Reference Standards 〈11〉

USP Acetylcholine Chloride RS