Carbachol

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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C₆H₁₅ClN₂O₂ 182.65

Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,N-trimethyl-, chloride;

Choline chloride, carbamate CAS RN®: 51-83-2; UNII: 8Y164V895Y.

1 DEFINITION

Carbachol contains NLT 99.0% and NMT 101.0% of carbachol (C₆H₁₅ClN₂O₂), calculated on the dried basis.

2 IDENTIFICATION

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

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B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride

Sample solution: 50 mg/mL of Carbachol in water (USP 1-May-2021)

Acceptance criteria: Meets the requirements (USP 1-May-2021)

3 ASSAY

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Procedure

Sample: 150 mg of Carbachol

Titrimetric system

(See Titrimetry 〈541〉.) (USP 1-May-2021)

Mode: Direct titration

Titrant: 0.1 N perchloric acid in glacial acetic acid VS (USP 1-May-2021)

Endpoint detection: Potentiometric

Blank: 10 mL of glacial acetic acid TS and 40 mL of acetic anhydride

Analysis: Dissolve the Sample in a mixture of 10 mL of glacial acetic acid TS and 40 mL of acetic anhydride. Titrate with Titrant. Perform a blank determination, and make any necessary correction

(USP 1-May-2021) . Each mL of 0.1 N perchloric acid is equivalent to 18.27 mg of carbachol (C H ClN O ).

Acceptance criteria: 99.0%–101.0% on the dried basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

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Ordinary Impurities 〈466〉

Solvent: Methanol and water (80:20)

Eluant: Alcohol

Visualization: 17

Analysis

Samples: Test Solution and Standard Solutions

Proceed as directed in the chapter except use a thin-layer chromatographic plate coated with acid-washed aluminum oxide. (USP 1-May-2021)

Acceptance criteria: Meets the requirements

5 SPECIFIC TESTS

Melting Range or Temperature 〈741〉: 200°–204°, with some decomposition

Loss on Drying 〈731〉

Sample: 1 g of Carbachol

Analysis: Dry the Sample at 105° for 2 h.

Acceptance criteria: NMT 2.0%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Carbachol RS