Sufentanil Citrate 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

Sufentanil Citrate Injection is a sterile solution of Sufentanil Citrate in Water for Injection. It contains the equivalent of NLT 90.0% and NMT 110.0% of the labeled amount of sufentanil citrate (C₂₂H₃₀N₂O₂S · C₆H₈O₇).

[Caution—Handle Sufentanil Citrate Injection with great care, because it is a potent opioid analgesic.]

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020)

Sample solution: 50 μg/mL

Medium: Use Mobile phase prepared as directed in the Assay. [Note—For samples that do not require dilution to achieve 50 μg/mL, use Water for Injection as the medium for the Standard solution.]

Acceptance criteria: Meets the requirements

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

3 ASSAY

3.1 Procedure

Mobile phase: Methanol, acetonitrile, and 0.13 M ammonium acetate (45:24:31). Adjust with glacial acetic acid or ammonium hydroxide to a pH of 7.2.

Standard solution: 0.075 mg/mL of USP Sufentanil Citrate RS in water

Sample solution: Use Sufentanil Citrate Injection.

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 228 nm

Column: 4.6-mm × 25-cm; packing L1

Flow rate: 1.5 mL/min

Injection volume: 100 μL

3.3 System suitability

Sample: Standard solution

3.4 Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of sufentanil citrate (C₂₂H₃₀N₂O₂S · C₆H₈O₇) 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 Sufentanil Citrate RS in the Standard solution (mg/mL)

C_U = nominal concentration of sufentanil citrate in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: NMT 6.25 USP Endotoxin Units/mL

pH 〈791〉: 3.5–6.0

Particulate Matter in Injections 〈788〉: Meets the requirements for small-volume injections

Other Requirements: Meets the requirements in Injections and Implanted Drug Products 〈1〉

5 ADDITIONAL REQUIREMENTS

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

USP Reference Standards 〈11〉

USP Sufentanil Citrate RS