Aztreonam 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

Aztreonam Injection is a sterile solution of Aztreonam and Arginine and a suitable osmolality-adjusting substance in Water for Injection. It contains NLT 90.0% and NMT 120.0% of the labeled amount of aztreonam (C₁₃H₁₇N₅O₈S₂).

2 IDENTIFICATION

A. The retention times of the major peaks of the Sample solution correspond to those of the Standard solution, as obtained in the Assay.

3 ASSAY

PROCEDURE

Buffer: 1.15 g/L of monobasic ammonium phosphate in water. Before final dilution, adjust with phosphoric acid to a pH of 2.0 ± 0.1.

Mobile phase: Acetonitrile and Buffer (75:25)

System suitability solution: 0.2 mg/mL each of USP Aztreonam RS and USP Open Ring Aztreonam RS in Mobile phase

Standard solution: 0.2 mg/mL each of USP Aztreonam RS and USPL-Arginine RS in Mobile phase

Sample solution: Nominally 0.2 mg/mL of aztreonam from Injection in Mobile phase

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 206 nm

Column: 4-mm x 25-cm; 5- to 10-µm packing L20

Flow rate: 1 mL/min

Injection volume: 20 µL

System suitability

Sample: System suitability solution

[NOTE-The relative retention times for aztreonam and open ring aztreonam are 0.8 and 1.0, respectively. The relative retention times for aztreonam and arginine are 0.3 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 2.0 between aztreonam and open ring aztreonam

Tailing factor: NMT 2.0 for the aztreonam peak

Relative standard deviation: NMT 2.0% for the aztreonam peak

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of aztreonam (C₁₃H₁₇N₅O₈S₂) in the portion of Injection taken:

Result = (r_u /r_s ) × (C_s /C_u ) × P × F × 100

r_u = peak response of aztreonam from the Sample solution

r_s = peak response of aztreonam from the Standard solution

C_s = concentration of USP Aztreonam RS in the Standard solution (mg/mL)

C_u = nominal concentration of aztreonam in the Sample solution (mg/mL)

P = potency of aztreonam in USP Aztreonam RS (µg/mg)

F = conversion factor, 0.001 mg/µg

Acceptance criteria: 90.0%–120.0%

Acceptance criteria: 90.0%-120.0%

4 SPECIFIC TESTS

BACTERIAL ENDOTOXINS TEST (85): NMT 0.25 USP Endotoxin Unit/mg of aztreonam

STERILITY TESTS (71): It meets the requirements when tested as directed for Test for Sterility of the Product to Be Examined. Membrane Filtration.

PH(791): 4.5-7.5

PARTICULATE MATTER IN INJECTIONS (788): It meets the requirements for small-volume injections.

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve as described in Packaging and Storage Requirements (659). Injection Packaging, Packaging for constitution.

Maintain in the frozen state.

LABELING: It meets the requirements for Labeling (7), Labels and Labeling for Injectable Products. The label states that the Injection is to be thawed just prior to use, describes conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.

USP REFERENCE STANDARDS (11)

USP-Arginine RS

USP Aztreonam RS

USP Open Ring Aztreonam RS

(2S,3S)-2-((Z)-2-(2-Aminothiazol-4-yl]-2-[2-carboxypropan-2-yloxyimino]acetamido)-3-(sulfoamino) butanoic acid.

C₁₃H₁₉N₅O₉S₂               453.45