Succinylcholine 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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C₁₄H₃₀Cl₂N₂O₄ (anhydrous) 361.31

C₁₄H₃₀Cl₂N₂O₄ · 2H₂O 397.34

Ethanaminium, 2,2'-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl]-, dichloride;

Choline chloride succinate (2:1) CAS RN®: 71-27-2; UNII: I9L0DDD30I.

Dihydrate CAS RN®: 6101-15-1; UNII: 8L0S1G435E.

1 DEFINITION

Succinylcholine Chloride contains NLT 96.0% and NMT 102.0% of succinylcholine chloride (C₁₄H₃₀Cl₂N₂O₄ ), calculated on the anhydrous basis.

[Caution—Succinylcholine chloride is a neuromuscular blocking agent. Great care should be taken when handling to avoid inhalation of dust or contact with skin.]

2 IDENTIFICATION

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

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

C. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Meets the requirements

3 ASSAY

Procedure

Mobile phase: Prepare a 1-in-10 solution of 1 N aqueous tetramethylammonium chloride in methanol. Adjust with hydrochloric acid to a pH of about 3.0.

Standard solution: 8.8 mg/mL of USP Succinylcholine Chloride RS prepared as follows. Transfer a suitable amount of USP Succinylcholine

Chloride RS to a suitable volumetric flask and dissolve in 40% of the total volume of water. Dilute with Mobile phase to volume while mixing.

Sample solution: 8.8 mg/mL of Succinylcholine Chloride prepared as follows. Transfer a suitable amount of Succinylcholine Chloride to a suitable volumetric flask and dissolve in 40% of the total volume of water. Dilute with Mobile phase to volume while mixing.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 214 nm

Column: 4-mm × 25-cm; 10-μm packing L3

Flow rate: 0.75 mL/min

Injection volume: 10 μL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.5

Relative standard deviation: NMT 1.5%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of succinylcholine chloride (C₁₄H₃₀Cl₂N₂O₄) in the portion of Succinylcholine Chloride taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of succinylcholine chloride from the Sample solution

r_S = peak response of succinylcholine chloride from the Standard solution

C_S = concentration of USP Succinylcholine Chloride RS in the Standard solution (mg/mL)

C_U = concentration of Succinylcholine Chloride in the Sample solution (mg/mL)

Acceptance criteria: 96.0%–102.0% on the anhydrous basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.2%

Organic Impurities

Buffer: 3.85 g/L of anhydrous sodium 1-pentanesulfonate, 2.9 g/L of sodium chloride, and 1% (v/v) 1 N sulfuric acid in water

Mobile phase: Acetonitrile and Buffer (5:95)

System suitability solution: 0.5 mg/mL each of USP Citric Acid RS and USP Succinic Acid RS in Mobile phase

Standard solution: 0.05 mg/mL of USP Succinylmonocholine Chloride RS in Mobile phase

Sample solution: 10 mg/mL of Succinylcholine Chloride in Mobile phase

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 214 nm

Column: 4.6-mm × 25-cm; 5-μm packing L1

Autosampler temperature: 4°

Flow rate: 1 mL/min

Injection volume: 50 μL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 2.9 between the citric acid and succinic acid peaks, System suitability solution

Relative standard deviation: NMT 3.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each impurity in the portion of Succinylcholine Chloride taken:

Result = (r_U/r_S ) × (C_S /C_U ) × (1/F) × 100

r_U = peak area of each impurity from the Sample solution

r_S = peak area of succinylmonocholine chloride from the Standard solution

C_S = concentration of USP Succinylmonocholine Chloride RS in the Standard solution (mg/mL)

C_U = concentration of Succinylcholine Chloride in the Sample solution (mg/mL)

F = relative response factor (see Table 1)

Acceptance criteria: See Table 1.

Table 1

^a Included for identifucation purposes only. Begin integration after this peak, if present.

^b May occur as a doublet. Acceptance criteria is for the sum of both peaks.

^c Total impurities include the sum of the results in the tests for Organic Impurities and Limit of Choline.

Limit of Choline

Solution A: 0.62 g/L of methanesulfonic acid

Solution B: 4.8 g/L of methanesulfonic acid

Mobile phase: See Table 2. Pre-equilibrate the instrument for NLT 3 min before each injection. [Note—Alternatively, the Mobile phase can be

generated electrolytically using an automatic eluant generator.]

Table 2

System suitability solution: 10 μg/mL of USP Choline Chloride RS and 5 μg/mL of USP Potassium Chloride RS

Standard solution: 8 μg/mL of USP Choline Chloride RS

Sample solution: 2 mg/mL of Succinylcholine Chloride. Store at 4° immediately following preparation.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: Conductivity with suppression

Cell temperature: 35°

Columns

Guard: 2-mm × 5-cm; packing L98

Analytical: 2-mm × 25-cm; packing L97

Temperatures

Autosampler: 4°

Column: 35°

Flow rate: 0.25 mL/min

Injection volume: 5 μL

System suitability

Sample: System suitability solution

[Note—The relative retention times for potassium and choline are 0.6 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 5.0 between the choline and potassium peaks

Relative standard deviation: NMT 3.0% for choline

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of choline in the portion of Succinylcholine Chloride taken:

Result = (r_U/r_S) × (C_S/C_U) × (M_r1 /M_r2 ) × 100

r_U = peak response of choline from the Sample solution

r_S = peak response of choline from the Standard solution

C_S = concentration of USP Choline Chloride RS in the Standard solution (mg/mL)

C_U = concentration of Succinylcholine Chloride in the Sample solution (mg/mL)

M_r1 = molecular weight of choline, 104.17

M_r2 = molecular weight of choline chloride, 139.62

Acceptance criteria: NMT 0.3%

5 SPECIFIC TESTS

Water Determination 〈921〉, Method I: NMT 10.0%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers. Store at controlled room temperature.

Change to read:

USP Reference Standards 〈11〉

USP Choline Chloride RS

USP Citric Acid RS

USP Potassium Chloride RS

USP Succinic Acid RS

USP Succinylcholine Chloride RS

USP Succinylmonocholine Chloride RS

Ethanaminium, 2-(3- (ERR 1-Jan-2022) carboxy-1-oxopropoxy)-N,N,N-trimethyl-, chloride;

Also known as 2-[(3-Carboxypropanoyl)oxy]-N,N,N-trimethylethan-1-aminium chloride. (ERR 1-Jan-2022)

C₉H₁₈ClNO₄ 239.70