|
|
;)
435.43
,3
(Z)]]-.
[78110-38-0].
197K
—
Do not dry the specimen.
85—
Where the label states that aztreonam is sterile or must be subjected to further processing during the preparation of injectable dosage forms, it contains not more than 0.17 USP Endotoxin Unit per mg of aztreonam.
71—
Where the label states that Aztreonam is sterile, it meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, using Fluid A to which 23.4 g of sterile arginine has been added to each 1000 mL.
921:
not more than 2.0%.
281:
not more than 0.1%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid.
231:
0.003%.
467:
meets the requirements.
621).
621)—The liquid chromatograph is equipped with a 270-nm detector, a 2-mm × 10-cm precolumn containing packing L2, and a 4.6-mm × 30-cm analytical column containing packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.6 for aztreonam and 1.0 for aztreonam E-isomer; the resolution, R, between aztreonam and aztreonam E-isomer is not less than 2.0; the column efficiency as determined from the aztreonam peak is not less than 1000 theoretical plates; the tailing factor for the aztreonam peak is not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%.