Gemifloxacin is a synthetic fluoroquinolone antibacterial API with broad-spectrum activity against susceptible Gram-positive and Gram-negative bacteria. It inhibits bacterial DNA gyrase and topoisomerase IV, enzymes required for bacterial DNA replication and repair.
Gemifloxacin is commonly used in pharmaceutical formulations as gemifloxacin mesylate, the mesylate salt of gemifloxacin.
Gemifloxacin Mesylate is a specialized antibacterial pharmaceutical active ingredient belonging to the fluoroquinolone class. It is primarily associated with oral formulations used for susceptible bacterial respiratory tract infections.
CAS Number: 210312-27-1
Molecular Formula: C18H20FN5O4·CH4O3S
Molecular Weight: 485.49 g/mol
Common Form: Gemifloxacin Mesylate
Drug Class: Fluoroquinolone Antibacterial
Therapeutic Class: Antibacterial
Therapeutic Area: Infectious Diseases
Gemifloxacin inhibits bacterial DNA gyrase and topoisomerase IV. These enzymes are essential for DNA replication, transcription and chromosome maintenance. Inhibition of these enzymes interferes with bacterial DNA synthesis and ultimately leads to bacterial cell death.
Gemifloxacin is used for susceptible bacterial infections, particularly acute bacterial exacerbations of chronic bronchitis and mild-to-moderate community-acquired pneumonia caused by susceptible microorganisms, depending on the applicable approved product labeling.
Gemifloxacin Mesylate is the methanesulfonate salt of gemifloxacin. Salt formation provides the pharmaceutical form used in marketed drug products and is particularly relevant to formulation and API manufacturing.
Gemifloxacin demonstrates activity against a range of susceptible microorganisms, including selected Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and other susceptible bacterial species. Activity depends on the organism, susceptibility profile and resistance mechanisms.
Gemifloxacin Mesylate is a synthetic fluorinated quinolone derivative. It contains a quinolone core with fluorine substitution and nitrogen-containing functional groups. The molecular formula of the mesylate form is C19H24FN5O7S, with a molecular weight of 485.49 g/mol.
Gemifloxacin Mesylate API quality evaluation may include identification by IR, HPLC and LC-MS, assay by HPLC, related substances, water content, residual solvents, residue on ignition, elemental impurities and other applicable pharmaceutical quality-control tests.
Gemifloxacin Mesylate should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Final storage conditions should follow validated stability data and the applicable material-specific specification.
Gemifloxacin is relevant to antibacterial drug development and research involving fluoroquinolone mechanisms, bacterial DNA gyrase inhibition, topoisomerase IV inhibition and antimicrobial resistance.
Gemifloxacin is a fluoroquinolone antibacterial API commonly supplied as Gemifloxacin Mesylate. It has CAS Number 210312-27-1, molecular formula C18H20FN5O4·CH4O3S, and molecular weight 485.49 g/mol. Its antibacterial action is based on inhibition of bacterial DNA gyrase and topoisomerase IV.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 3.0 – 5.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |