What is Gatifloxacin?
Gatifloxacin API Powder is a fourth-generation fluoroquinolone broad-spectrum antibacterial active pharmaceutical ingredient (API) with the chemical formula C₁₉H₂₂FN₃O₄ and a molecular weight of 375.39. This product is a white to off-white crystalline powder. Its structural feature is the methoxy group at the C-8 position, a unique chemical modification that enhances its antibacterial activity against both Gram-positive and Gram-negative bacteria. Gatifloxacin was first discovered by Kyorin Pharmaceutical Co., Ltd. in Japan for the treatment of respiratory infections. Its antibacterial mechanism of action involves inhibiting bacterial DNA gyrase and topoisomerase IV, thereby blocking bacterial DNA replication, transcription, and repair processes. This API is a core component in the preparation of eye drops, tablets, and injectable formulations.
How does gatifloxacin exert its antibacterial effects in ophthalmic and systemic infections?
In ophthalmology, Gatifloxacin API powder is a core ingredient in eye drop formulations, clinically used to treat acute bacterial conjunctivitis caused by susceptible bacterial strains. Specific pathogens it targets include Gram-positive and Gram-negative bacteria. In the treatment of systemic infections, gatifloxacin has been used to treat community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute sinusitis, urinary tract infections, and pyelonephritis, among other respiratory and urinary tract infections. Furthermore, in pharmaceutical manufacturing, this active pharmaceutical ingredient is a core component in the preparation of oral solid dosage forms, intravenous solutions, and eye drops, and is widely used in generic drug development and the production of ophthalmic anti-infective agents. In basic research, this compound is also frequently used as a tool drug for fluoroquinolone antibiotics, in studies of bacterial DNA replication inhibition mechanisms and antimicrobial resistance assessment.
How can Gatifloxacin be used to construct a multi-level antibacterial and bactericidal pharmacological system?
Gatifloxacin API Powder simultaneously inhibits the activity of two key enzymes in bacteria: DNA gyrase and topoisomerase IV. This blocks bacterial DNA replication, transcription, and repair processes, preventing the proliferation of pathogenic bacteria at its source. It exhibits potent bactericidal effects against Gram-positive bacteria, Gram-negative bacteria, some anaerobes, and mycoplasma and chlamydia, with an antibacterial coverage far superior to earlier quinolone raw materials. This product is rapidly absorbed and takes effect when administered orally, topically via the eye, or intravenously. It has strong tissue permeability, maintaining effective antibacterial concentrations in the lungs, urinary tract, and intraocular tissues. It can be used alone as a single-agent anti-infective agent or rationally combined with other antibacterial excipients to optimize treatment regimens, playing an irreplaceable pharmacological value in the treatment of systemic infections and localized bacterial infections of the eye.
MF of Gatifloxacin
Molecular Formula: C19H22FN3O4
Molecular Weight: 375.40
Melting Point: 162～166℃
Boiling Point: 587.2°C
Density: 1.36g/cm³
PH: 5.2～7.0
Product Specification
| Item | Specification | Result |
| Appearance | White to off-white crystalline powder | Complies |
| Identification | IR/HPLC consistent with standard | Complies |
| Assay | 98.5% ~ 101.5% | 99.76% |
| Purity | ≥ 99.0% | 99.3% |
| Loss on Drying | ≤0.5% | 0.24% |
| Residue on Ignition | ≤0.1% | 0.06% |
| Heavy Metals | ≤ 10 ppm | < 5 ppm |
| Conclusion | Complies with enterprise standard | |
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FAQ：
Q1: Does Gatifloxacin exhibit significant antibacterial effects against drug-resistant strains?
A1: It can dually block key enzymes for bacterial replication, has strong inhibitory power against a variety of drug-resistant Gram-positive and Gram-negative bacteria, has stable antibacterial activity, and the finished product has a stable and reliable antibacterial effect in clinical practice.
Q2: Can Gatifloxacin's tissue penetration be compatible with ocular infection treatments?
A2: The drug has excellent penetration and can maintain effective antibacterial concentrations in ocular tissues, respiratory tracts, and urinary tracts, making it compatible with various infection treatments such as eye drops and oral tablets.
Q3: What are the recommended concentrations and pH ranges for gatifloxacin in eye drops?
A3: The recommended concentration for eye drops is 0.3%, with a pH range of 5.0-7.2. We can provide detailed solubility profiles and pH-stability data with the shipment to help you optimize your formulation and save time in the initial process development phase.
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