Quick Facts
| CAS Number | 82419-36-1 |
|---|---|
| Molecular Formula | C18H20FN3O4 |
| Molecular Weight | 361.4 |
| Pharmacopoeia | USP/BP |
| Packaging | 25 KG/DRUM |
Product Overview
Ofloxacin was developed by Daiichi Seiyaku (now Daiichi Sankyo) in Japan and first approved in 1985, following the earlier success of norfloxacin. As a second-generation fluoroquinolone, it introduced a critical advantage over first-generation nalidixic acid derivatives: an oxazine ring that expanded the antibacterial spectrum to include Staphylococcus aureus, Streptococcus pneumoniae, and atypical respiratory pathogens such as Chlamydia pneumoniae and Mycoplasma pneumoniae. This broader coverage, combined with excellent tissue penetration, established ofloxacin as one of the most prescribed fluoroquinolones worldwide through the 1990s and 2000s.
Ofloxacin exists as a racemic mixture of R- and S-enantiomers. The S-enantiomer, levofloxacin, is responsible for essentially all antibacterial activity and was subsequently isolated and marketed as a standalone product. However, ofloxacin racemate remains widely used because its manufacturing cost per gram of active moiety is significantly lower than isolated levofloxacin, making it the preferred API for cost-sensitive markets across Asia, Africa, and Latin America. In many national essential medicines lists, ofloxacin 200 mg and 400 mg tablets remain first-line therapy for respiratory and urinary tract infections.
A defining pharmacokinetic feature is ofloxacin's near-complete oral bioavailability of approximately 98%, which means oral tablets achieve essentially the same systemic drug levels as intravenous infusion. This property, rare among antibiotics, allows clinicians to transition hospitalized patients from IV to oral therapy without dose adjustment — a practice known as "IV-to-PO switch" that reduces hospital length of stay and catheter-related complications. Serum protein binding is minimal (approximately 20-25%), enabling high free drug concentrations at infection sites throughout the body.
As of mid-2026, global ofloxacin API demand remains steady, supported by its inclusion in WHO and national essential medicines lists. Production is concentrated in China and India, with Chinese manufacturers in Zhejiang, Jiangsu, and Shandong provinces supplying the majority of global volumes. However, fluoroquinolone APIs face increasing regulatory scrutiny over genotoxic impurities and environmental persistence, making GMP compliance and impurity control critical differentiators. KingWish supplies GMP-certified ofloxacin API meeting USP and EP specifications, with full batch-specific documentation for pharmaceutical manufacturers worldwide.
Quality Specifications
| Purity (HPLC) | ≥ 98.5% (dried basis), per USP/EP monograph |
|---|---|
| Related Substances | Individual impurity ≤ 0.3%, total impurities ≤ 1.0% (USP/EP) |
| Chiral Purity | R-enantiomer content confirmed by chiral HPLC (EP requirement) |
| Residual Solvents | Compliant with ICH Q3C; class 1 and 2 solvents below permitted daily exposure limits |
| Heavy Metals | ≤ 20 ppm |
| GMP Status | Manufactured under ICH Q7 GMP conditions |
Applications
Oral Tablets & Capsules
200 mg and 400 mg tablets for respiratory and urinary tract infections. 98% oral bioavailability allows IV-to-oral switch without dose adjustment.
Ophthalmic Solution (0.3%)
Sterile ophthalmic drops for bacterial conjunctivitis, corneal ulcers, and perioperative prophylaxis. Broad-spectrum coverage of common ocular pathogens.
Therapeutic Areas
- Respiratory tract: Community-acquired pneumonia, acute bronchitis, chronic bronchitis exacerbations
- Urinary tract: Uncomplicated and complicated UTIs, pyelonephritis, prostatitis
- Ophthalmic: Bacterial conjunctivitis, corneal ulcers, blepharitis
- ENT: Otitis externa, chronic suppurative otitis media
- Pelvic inflammatory disease: Combination therapy for PID with metronidazole
Sourcing Ofloxacin API: Key Checks
Documentation
Request CoA with HPLC purity and chiral purity data, residual solvent statement (ICH Q3C), heavy metals report, and GMP certificate. For regulated markets, verify DMF filing status and request a Letter of Authorization (LOA) if referencing the supplier's DMF.
Red Flags
Missing chiral purity data (the inactive R-enantiomer inflates total assay), high individual impurity peaks above 0.5%, reluctance to share batch CoA before order, polymorphic inconsistencies, and prices significantly below market range may indicate non-GMP production.
Packaging & Logistics
Standard: 25 KG/DRUM with double PE liner. Custom packaging available. Store at room temperature (15-30 deg C), protect from light and moisture. Standard lead time 4-6 weeks. Air and sea freight options available.
Market Context
Ofloxacin remains on the WHO Essential Medicines List and multiple national EMLs. While levofloxacin has displaced some market share, ofloxacin racemate continues to dominate cost-sensitive markets. Regulatory focus on fluoroquinolone genotoxic impurities and environmental impact is increasing, favoring GMP-compliant suppliers with robust quality systems.