Gemifloxacin Impurities

General Information

Gemifloxacin Impurities and Gemifloxacin

Daicel Pharma offers excellent-quality Gemifloxacin impurities, such as Gemifloxacin-E-isomer. They are vital for evaluating the quality, stability, and biological safety of Gemifloxacin. Further, Daicel Pharma specializes in the custom synthesis of Gemifloxacin impurities and ensures their worldwide delivery.
Gemifloxacin [CAS: 175463-14-6] is a fluoronaphthyridine derivative and a broad-spectrum antibiotic. It is active against gram-positive and gram-negative bacteria and bacterial strains resistant to other antibiotics. It is effective against Streptococcus pneumoniae strains. It is a third-generation antibacterial agent.

Gemifloxacin: Use and Commercial Availability 

Gemifloxacin is available under Factive as an oral formulation. It treats patients with mild to moderate community-acquired pneumonia (CAP). Further, it treats acute exacerbation of chronic bronchitis caused by Haemophilus influenzae, H. parainfluenzae, or Moraxella catarrhalis. As an antibacterial agent, it is effective against pathogens causing respiratory tract infections.

Gemifloxacin Structure and Mechanism of Action

The chemical name of Gemifloxacin is 7-[(4Z)-3-(Aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid. The chemical formula for Gemifloxacin is C₁₈H₂₀FN₅O₄, and its molecular weight is approximately 389.38 g/mol.

Gemifloxacin blocks bacterial DNA synthesis by inhibiting DNA gyrase and topoisomerase IV, which are necessary for bacterial growth.

Gemifloxacin Impurities and Synthesis

During Gemifloxacin synthesis1, impurities form that may affect the safety and efficacy of the drug. They form during the synthetic process, purification, or storage of Gemifloxacin. Therefore, Gemifloxacin impurities must be controlled and monitored throughout the drug’s development.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Gemifloxacin impurities, which includes Gemifloxacin-E-isomer. We provide the CoA from a cGMP-compliant analytical facility. It gives complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We provide additional analytical data on request. Daicel Pharma can prepare any unidentified Gemifloxacin impurity or degradation product. In addition, Daicel Pharma offers highly purified, stable isotope-labeled standards of Gemifloxacin. The clients of Daicel Pharma can expect a complete characterization report on delivery.