Succinylcholine Chloride Injection

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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1 DEFINITION

Succinylcholine Chloride Injection is a sterile solution of Succinylcholine Chloride in a suitable aqueous vehicle. It contains NLT 90.0% and NMT 110.0% of the labeled amount of anhydrous succinylcholine chloride (C₁₄H₃₀Cl₂N₂O₄).

2 IDENTIFICATION

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

B. Thin-Layer Chromatographic Identification Test 〈201〉

Standard solution: 1 mg/mL of USP Succinylcholine Chloride RS in water

Sample solution: Nominally 1 mg/mL of succinylcholine chloride from Injection in water

2.1 Chromatographic system

(See Chromatography 〈621〉, Thin-Layer Chromatography.)

Adsorbent: 0.25-mm layer of chromatographic silica gel

Application volume: 1 μL

Developing solvent system: Acetone and 1 N hydrochloric acid (1:1)

2.2 Analysis

Samples: Standard solution and Sample solution

Proceed as directed in the chapter. To locate the spots, heat the plate at 105° for 5 min, cool, and spray with potassium Bismuth iodide

TS, then heat again at 105° for 5 min.

Acceptance criteria: Meets the requirements

3 ASSAY

3.1 Procedure

[Note—Because the Mobile phase used in this procedure has a fairly high concentration of chloride ion and a low pH, it is advisable to rinse the entire system with water following use of this Mobile phase.]

Mobile phase: Prepare a solution (1 in 10) of 1 N tetramethylammonium chloride in methanol. Pass this solution through a 0.45-μm membrane fIlter, and adjust with hydrochloric acid to a pH of 3.0.

Standard solution: 8.8 mg/mL of USP Succinylcholine Chloride RS prepared as follows. Transfer 88 mg of USP Succinylcholine Chloride RS to a 10-mL volumetric flask and add a volume of water corresponding to the solvent composition of the Sample solution. Dilute with Mobile phase to volume. Prepare the Standard solution concurrently with the Sample solution.

Sample solution: Nominally 8.0 mg/mL of succinylcholine chloride prepared as follows. Transfer a volume of Injection equivalent to 80 mg of anhydrous succinylcholine chloride to a 10-mL volumetric flask and dilute with Mobile phase to volume.

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 214 nm

Column: 4-mm × 25-cm; packing L3

Flow rate: 0.75 mL/min

Injection volume: 10 μL

3.3 System suitability

Sample: Standard solution

3.4 Suitability requirements

Tailing factor: NMT 2.5

Relative standard deviation: NMT 1.5%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of anhydrous succinylcholine chloride (C₁₄H₃₀Cl₂N₂O₄) in the portion of Injection taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

C_U = nominal concentration of succinylcholine chloride in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: NMT 2.0 USP Endotoxin Units/mg of succinylcholine chloride

pH 〈791〉: 3.0–4.5

Other Requirements: It meets the requirements in Injections and Implanted Drug Products 〈1〉.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass, in a refrigerator.

Labeling: Label it to indicate, as its expiration date, the month and year NMT 2 years from the month during which the Injection was last

assayed and released by the manufacturer.

USP Reference Standards 〈11〉

USP Succinylcholine Chloride RS