GMP White APIs Aztreonam Medical Intermediate Cas 78110-38-0

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White APIs Aztreonam Traditional Chinese Medicine Cas 78110-38-0 Aztreonam Description Aztreonam is the first totally synthetic monocyclic -lactam antibiotic. Aztreonam is resistant to beta-lactamases and is used in gram-negative infections, especially of the meninges, bladder, and kidneys. It may cause a superinfection with gram-positive organisms. Specification - - - - Items | Specification | Analysis Result | Appearance | White, odorless crystalline powder | Conform | Identification | The retention times of the major peaks in the chromatogram of the assay preparation correspond to those of the Standard preparation obtained in the assay | Conform | Color of Solution | Not more than yellow or greenish- yellow Reference Solution II | Conform | Clarity of solution | Not more than Turbidity Standard I | Conform | PH | 4.5~7.5 | 5.2 | Related Impurities | Single impurities | Not more than1.0% | 0.34% | Total impurities | Not more than3.0% | 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 | 10m, no more than 2500/g 25m, 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% | - - - -

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ANHUI BBCA PHARMACEUTICAL CO.,LTD

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