Levofloxacin Hemihydrate is the hemihydrate form of levofloxacin, a synthetic fluoroquinolone antibacterial active pharmaceutical ingredient (API). It is the S-enantiomer of ofloxacin and acts by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes required for bacterial DNA replication.
Levofloxacin Hemihydrate is identified by CAS Number 138199-71-0 and has the molecular formula C18H20FN3O4·½H2O with a molecular weight of 370.38 g/mol. It is widely used as a pharmaceutical API in the development and manufacture of antibacterial formulations.
Levofloxacin Hemihydrate belongs to the fluoroquinolone class of antibacterial compounds. Its antibacterial activity results primarily from inhibition of bacterial DNA gyrase and topoisomerase IV, thereby interfering with DNA replication and other essential bacterial processes.
The hemihydrate form contains approximately 2.0% to 3.0% water and is characterized by its specific optical rotation and pharmaceutical quality attributes. USP defines Levofloxacin at 98.0% to 102.0% of C18H20FN3O4, calculated on the anhydrous basis.
Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. These enzymes are essential for bacterial DNA replication, transcription, repair and recombination. Inhibition of these enzymes disrupts bacterial DNA processes and contributes to the antibacterial activity of levofloxacin.
Swapproop Drugs and Pharmaceuticals provides sourcing and supply support for Levofloxacin Hemihydrate API for qualified pharmaceutical requirements. The product can be evaluated according to applicable pharmacopoeial and customer-specific quality requirements.
For Levofloxacin Hemihydrate API availability, technical documentation, specifications and commercial requirements, contact Swapproop Drugs and Pharmaceuticals.
Levofloxacin Hemihydrate has CAS Number 138199-71-0, molecular formula C18H20FN3O4·½H2O and molecular weight 370.38 g/mol. The anhydrous levofloxacin component has CAS Number 100986-85-4 and molecular weight 361.37 g/mol.
| 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 0.2% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.3% |
| Total Impurities | NMT 0.5% |
| Water Content | 2.0% – 3.0% |
| Specific Rotation | −92° to −106° at 20°C |