Aztreonam for 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 for Injection is a dry mixture of sterile Aztreonam and Arginine. It contains NLT 90.0% and NMT 105.0% of aztreonam (C₁₃H₁₇N₅O₈S₂), calculated on the anhydrous and arginine-free basis. Each container 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 USP L-arginine RS in Mobile phase

Sample solution 1: Nominally 0.2 mg/mL of aztreonam in Mobile phase from Aztreonam for Injection prepared as follows. Weigh one container of Aztreonam for Injection, transfer the contents to a suitable container, and dilute with Mobile phase to the appropriate volume.

Weigh the empty container, and calculate the weight, in mg, of Aztreonam for Injection used.

Sample solution 2: Nominally 0.2 mg/mL of aztreonam from Aztreonam for Injection constituted as directed below and diluted with Mobile phase.

Where the vial has a capacity of less than 100 mL, constitute with water using the volume of solvent specified in the labeling.

Where the vial capacity is ≥100 mL, constitute with 10 mL of water and dilute the entire withdrawable contents of the container with Mobile phase to obtain the final concentration.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 206 nm

FFIC

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 about 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, Sample solution 1, and Sample solution 2

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

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

r_u = peak response for aztreonam from Sample solution 1

r_s = peak response for aztreonam from the Standard solution

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

C_u = nominal concentration of Aztreonam for Injection in Sample solution 1 (mg/mL), corrected for water and arginine content (see Content of Arginine)

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

F = conversion factor, 0.001 mg/µg

Acceptance criteria: 90.0%–105.0% on the anhydrous and arginine-free basis

Calculate the percentage of the labeled amount of aztreonam (C₁₃H₁₇N₅O₈S₂) in each container of Aztreonam for Injection taken:

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

r_u = peak response for aztreonam from Sample solution 2

r_s = peak response for 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 Sample solution 2 (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%

4 OTHER COMPONENTS

Content of Arginine

Use the result of this test to calculate, on the anhydrous and arginine-free basis, the Assay result from Sample solution 1, obtained as directed in

the Assay.

Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution 1, Chromatographic system, and System

suitability: Proceed as directed in the Assay.

Analysis

Sample: Sample solution 1

Calculate the percentage of arginine (C₆H₁₄N₄O₂) in the portion of Aztreonam for Injection taken:

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

r_u = peak response for arginine from Sample solution 1

r_s = peak response for arginine from the Standard solution

C_s = concentration of USP l-Arginine RS in the Standard solution (mg/mL)

C_u = concentration of Aztreonam for Injection in Sample solution 1 (mg/mL)

5 PERFORMANCE TESTS

UNIFORMITY OF DOSAGE UNITS (905): Meets the requirements

6 SPECIFIC TESTS

CONSTITUTED SOLUTION: At the time of use, it meets the requirements for Injections and Implanted Drug Products (1), Specific Tests. Completeness and clarity of solutions.

BACTERIAL ENDOTOXINS TEST (85); It contains NMT 0.17 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)

Sample solution: 100 mg/mL of aztreonam

Acceptance criteria: 4.5-7.5

WATER DETERMINATION, Method (921): NMT 2.0%

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

OTHER REQUIREMENTS: It meets the requirements for Labeling (7), Labels and Labeling for Injectable Products.

7 ADDITIONAL REQUIREMENTS

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

USP REFERENCE STANDARDS (11)

USPL-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