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Aztreonam buffered with L-arginine
Presentation:
Product Name: Aztreonam
Specification: Sterile Raw Material
Assay: Contains C13H17N5O8S2 90.0~105.0%
Packing: Aluminium Tins,5kg/Tin,2tins/Carton
Description: White Odorless crystalline powder
CAS No:78110-38-0 C13H17N5O8S2
Items | Specification | Analysis Result | |
Appearance | White, odorless crystalline powder | Conform | |
Identification | The retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that of the principal peak in the chromatogram obtained with reference solution. | Conform | |
Color of Solution | Not more intensely colored than reference solution Y2 or GY2 | Conform | |
Clarity of solution | Not more pronounced than that of reference suspension I | Conform | |
PH | 4.5~7.5 | 5.2 | |
Related Impurities | Single impurities | Not more than1.00% | 0.34% |
Total impurities | Not more than3.00% | 1.25% | |
Water Content | Not more than 2.0% | 0.3% | |
Residue of ignition | Not more than 0.1% | Conform | |
Heavy Metals | Not more than 30ppm | Conform | |
Bacterial Endotoxins | Not more than 0.17EU/mg (Aztreonam) | Conform | |
Sterility Test | Sterile (without germs in 14 days) | Conform | |
Particulate matter | ≥10µm, no more than 2500/g ≥25µm, no more than 250/g | 1084 67 | |
Assay | Contain C13H17N5O8S2 90.0% ~105.0% (Calculated on anhydrous substance without L-Arginine ) | 99.5% | |
L-Arginine content | 42%~45% | 43.4% | |
Aztreonam buffered with L-arginine
