Aztreonam Impurities and Aztreonam
Daicel Pharma synthesizes high-quality Aztreonam impurities, including Aztreonam Ethyl ester and Aztreonam tert-butyl ester. These impurities are essential for evaluating the quality, stability, and safety of Aztreonam, which is an active pharmaceutical ingredient. Additionally, Daicel Pharma offers a customized synthesis of Aztreonam impurities for global delivery to meet the specific needs of our customers.
Aztreonam [CAS: 78110-38-0] is an antibiotic of the monobactam class. It is effective against aerobic gram-negative bacilli that are resistant to many beta-lactamases. It was initially extracted from Chromobacterium violaceum with bactericidal activity. Aztreonam treats infections caused by gram-negative aerobic microorganisms.
Aztreonam: Use and Commercial Availability
Aztreonam is a β-lactam antibiotic that treats or prevents infections caused by susceptible bacteria. It is effective against gram-negative aerobic bacteria. It improves respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. The drug is available under the brand names Azactam and Cayston.
Aztreonam Structure and Mechanism of Action
The chemical name of Aztreonam is 2-[[(Z)-[1-(2-Amino-4-thiazolyl)-2-[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]amino]-2-oxoethylidene]amino]oxy]-2-methylpropanoic acid. Its chemical formula is C13H17N5O8S2, and its molecular weight is approximately 435.4 g/mol.
Aztreonam binds to penicillin-binding bacteria, thus inhibiting bacterial cell wall synthesis and cell death.
Aztreonam Impurities and Synthesis
Aztreonam is a beta-lactam antibiotic that can cause the formation of impurities during its manufacturing process1. These impurities can arise from various sources, including starting materials, synthetic intermediates, and degradation products. Some of these impurities can be potentially toxic and may risk patient safety. Therefore, it is crucial to monitor and control the levels of Aztreonam impurities to ensure the safety and efficacy of the drug.
Daicel Pharma provides a Certificate of Analysis (CoA) for Aztreonam impurity standards, including Aztreonam Ethyl ester and Aztreonam tert-butyl ester. The CoA is generated from a cGMP-compliant analytical facility and includes comprehensive characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. We can also give additional characterization data like 13C-DEPT and CHN upon request. Daicel Pharma is capable of creating unknown Aztreonam impurities or degradation products. Each delivery has a complete characterization report.
- Sykes, Richard Brook; Parker, William Lawrence; Cimarusti, Christopher Michael; Koster, William Henry; Slusarchyk, William Allen; Fritz, Alan William; Floyd, David Mack, Beta-lactam antibiotics, EP48953A2, April 7, 1982
- Pilkiewicz, Frank G.; Remsburg, Beverly J.; Fisher, Susan M.; Sykes, Richard B., High-pressure liquid chromatographic analysis of aztreonam in sera and urine, Antimicrobial Agents and Chemotherapy, Volume: 23, Issue: 6, Pages: 852-6, 1983
Frequently Asked Questions
The shelf life of Aztreonam concerning impurities is determined through stability studies, which assess the degradation of the drug product over time and under different storage conditions.
Impurities in Aztreonam are managed in the pharmaceutical industry by implementing appropriate quality control measures, including good manufacturing practices (GMPs), analytical methods validation, and quality assurance (QA) procedures.
There are no impurities in Aztreonam that are known to be particularly toxic. However, their presence in the drug product must be controlled and kept below acceptable levels to ensure patient safety.
Yes, impurities in Aztreonam can affect the stability of the drug, as they may accelerate degradation or contribute to the formation of degradation products. So it is essential to monitor and control impurities to ensure drug stability.
Aztreonam impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).
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