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).
• A. The retention times of the major peaks of the Sample solution correspond to those of the Standard solution, as obtained in the Assay.
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 of 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: Equivalent to 0.2 mg/mL of aztreonam from Injection in Mobile phase
Detector: UV 206 nm
Pre-column: 4.6-mm × 5- to 10-cm saturator precolumn containing packing L27
Column: 4-mm × 25-cm analytical column containing packing L20
Flow rate: 1 mL/min
Injection size: 20 µL
Sample: System suitability solution
[NoteThe 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. ]
Resolution: NLT 2.0 between aztreonam and open ring aztreonam
Column efficiency: NLT 1000 theoretical plates determined from the aztreonam peak
Tailing factor: NMT 2.0 for the aztreonam peak
Relative standard deviation: NMT 2.0% for the aztreonam peak
Samples: Standard solution and Sample solution
Calculate the percentage of aztreonam (C13H17N5O8S2) in the portion of Injection taken:
Result = (rU/rS) × (CS/CU) × P × F × 100
Acceptance criteria: 90.0%120.0%
• Pyrogen Test 151: It meets the requirements, the test dose being a measured volume of Injection sufficient to provide 50 mg/kg 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: 4.57.5
• Particulate Matter in Injections 788: It meets the requirements for small-volume injections.
• Packaging and Storage: Preserve as described under Injections 1, Containers for Sterile Solids. Maintain in the frozen state.
• Labeling: It meets the requirements for Injections 1, Labels and Labeling. The label states that it 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
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USP35NF30 Page 2291