Aztreonam for Injection
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).
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.
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:
Equivalent to 0.2 mg/mL of aztreonam in Mobile phase from Aztreonam for Injection.
Weigh 1 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:
Equivalent to 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 equal to or greater than 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
Mode:
LC
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
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
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
Analysis
Samples:
Standard solution, Sample solution 1, and Sample solution 2
Calculate the percentage of aztreonam (C13H17N5O8S2) in the portion of Aztreonam for Injection taken:
Result = (rU/rS) × (CS/CU) × P × F × 100
| rU | = | = peak response for aztreonam from Sample solution 1 |
| rS | = | = peak response for aztreonam from the Standard solution |
| CS | = | = concentration of USP Aztreonam RS in the Standard solution (mg/mL) |
| CU | = | = 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 aztreonam (C13H17N5O8S2) in each container of Aztreonam for Injection taken:
Result = (rU/rS) × (CS/CU) × P × F × 100
| rU | = | = peak response for aztreonam from Sample solution 2 |
| rS | = | = peak response for aztreonam from the Standard solution |
| CS | = | = concentration of USP Aztreonam RS in the Standard solution (mg/mL). |
| CU | = | = 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% of the labeled content of aztreonam
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 = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response for arginine from Sample solution 1 |
| rS | = | = peak response for arginine from the Standard solution |
| CS | = | = concentration of USP l-Arginine RS in the Standard solution (mg/mL) |
| CU | = | = concentration of Aztreonam for Injection in Sample solution 1 |
PERFORMANCE TESTS
• Uniformity of Dosage Units 
905
:
Meets the requirements
905:
Meets the requirements
SPECIFIC TESTS
• Constituted Solution:
At the time of use, it meets the requirements for Injections 1, Constituted Solutions.
1, Constituted Solutions.
• Bacterial Endotoxins Test 85:
It contains NMT 0.17 USP Endotoxin Unit/mg of aztreonam.
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.
71:
It meets the requirements when tested as directed for Test for Sterility of the Product to be Examined, Membrane Filtration.
• Water Determination, Method I 921:
NMT 2.0%
921:
NMT 2.0%
• Particulate Matter in Injections 788:
Meets the requirements for small-volume injections
788:
Meets the requirements for small-volume injections
• Other Requirements:
It meets the requirements for Injections 1, Labeling.
1, Labeling.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve as described in Injections 1, Containers for Sterile Solids.
1, Containers for Sterile Solids.
• USP Reference Standards 11
11
USP l-Arginine RS 
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USP Aztreonam RS
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USP Endotoxin RS
USP Open Ring Aztreonam RS
C13H19N5O9S2 453.45
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C13H19N5O9S2 453.45
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2291
Pharmacopeial Forum: Volume No. 34(4) Page 906