Levofloxacin Hydrochloride (CAS No.: 177325-13-2) - Broad-Spectrum Fluoroquinolone Antibacterial for Systemic Infections
As a professional supplier of pharmaceutical-grade antibacterial active ingredients, we provide high-purity Levofloxacin Hydrochloride that strictly complies with global pharmacopoeia standards (USP, EP, BP, CP). A third-generation fluoroquinolone, it is the active (S)-enantiomer of ofloxacin-offering enhanced potency, broader antibacterial spectrum, and lower toxicity compared to racemic ofloxacin. It is widely used in human medicine for treating severe bacterial infections of the respiratory tract, urinary tract, skin, and soft tissues, and in select veterinary practice for companion animals-making it a critical agent in combating drug-resistant bacterial pathogens.
Product Basic Information
| Item | Details |
|---|---|
| Product Name | Levofloxacin Hydrochloride (Levofloxacin HCl) |
| CAS No. | 177325-13-2 |
| Synonyms | (S)-(-)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid monohydrochloride; Levaquin® (brand name for human formulations) |
| Molecular Formula | C₁₈H₂₀FN₃O₄·HCl |
| Molecular Weight | 415.83 |
| Appearance | White to pale yellow crystalline powder; Odorless or with a slight characteristic odor |
| Specification | - Pharmaceutical Grade: Purity ≥99.0% (HPLC); Assay (as levofloxacin) 98.0%–102.0%; Specific optical rotation [α]²⁰D -103° to -111° (in water, c=0.5); Loss on drying ≤0.5%; Residue on ignition ≤0.1%; Heavy metals (Pb≤10ppm, Hg≤1ppm, Cd≤1ppm); Residual solvents (methanol ≤300ppm, acetone ≤500ppm) |
| Melting Point | 218–222°C (with decomposition) |
| Solubility | Freely soluble in water (≥100 g/L at 25°C); Soluble in methanol, ethanol; Slightly soluble in acetone; Insoluble in chloroform, ether |
| Storage Conditions | Store in a cool (15–25°C), dry, light-protected container; Sealed to prevent moisture absorption and photodegradation (fluoroquinolone structure is light-sensitive); Shelf life: 36 months for pharmaceutical grade, 24 months for veterinary grade |
Core Functions & Mechanism of Action
Levofloxacin Hydrochloride CAS 177325-13-2 exerts a bactericidal effect by selectively inhibiting two key bacterial enzymes: DNA gyrase (topoisomerase II) and topoisomerase IV-both critical for bacterial DNA replication, transcription, repair, and chromosome segregation. Its (S)-enantiomer structure binds more tightly to these enzymes than the (R)-enantiomer (found in racemic ofloxacin), resulting in:
Enhanced potency: 2–8 times more active than ofloxacin against Gram-negative bacteria (e.g., Escherichia coli, Pseudomonas aeruginosa) and Gram-positive bacteria (e.g., Staphylococcus aureus, Streptococcus pneumoniae).
Broad spectrum: Active against both aerobic Gram-negative and Gram-positive pathogens, as well as atypical pathogens (e.g., Mycoplasma pneumoniae, Chlamydophila pneumoniae) and mycobacteria (e.g., Mycobacterium tuberculosis).
Post-antibiotic effect (PAE): Suppresses bacterial regrowth for 2–6 hours after drug levels drop below the minimum inhibitory concentration (MIC), allowing for once-daily dosing.
Core Applications
1. Human Pharmaceutical Field
Levofloxacin Hydrochloride CAS 177325-13-2 is approved for treating moderate-to-severe bacterial infections (not for mild infections or viral diseases like cold/flu) where oral or parenteral therapy is needed:
1.1 Respiratory Tract Infections
Community-Acquired Pneumonia (CAP): Treats CAP caused by S. pneumoniae (including penicillin-resistant strains), M. pneumoniae, or H. influenzae. Oral/IV dose: 500 mg once daily for 7–14 days, or 750 mg once daily for 5 days (short-course therapy for faster recovery).
Hospital-Acquired Pneumonia (HAP): Effective against HAP caused by P. aeruginosa or methicillin-sensitive S. aureus (MSSA). IV dose: 750 mg once daily for 7–14 days, adjusted for renal function.
Acute Bacterial Sinusitis: Treats infections unresponsive to first-line antibiotics (e.g., amoxicillin). Oral dose: 500 mg once daily for 10–14 days, or 750 mg once daily for 5 days.
1.2 Urinary Tract Infections (UTIs)
Complicated UTIs & Pyelonephritis: Treats severe kidney or urinary tract infections caused by multidrug-resistant E. coli or Klebsiella pneumoniae. Oral/IV dose: 750 mg once daily for 5 days, or 500 mg once daily for 10–14 days.
Uncomplicated UTIs: Oral dose: 250 mg once daily for 3 days (short-course therapy to reduce resistance risk).
1.3 Skin & Soft Tissue Infections
Cellulitis, Abscesses, & Wound Infections: Treats infections caused by S. aureus (MSSA) or Streptococcus pyogenes. Oral/IV dose: 750 mg once daily for 7–10 days, with surgical debridement if needed.
1.4 Other Infections
Tuberculosis (TB): Used as a second-line agent for drug-resistant TB (combined with other anti-TB drugs). Dose: 500–750 mg once daily for 6–12 months.
Atypical Pathogen Infections: Treats Legionella pneumophila (Legionnaires' disease) or Chlamydia trachomatis (urethritis). IV/oral dose: 500 mg once daily for 7–14 days.
2. Veterinary Field (Companion Animals)
is approved for dogs (not cats-high risk of retinal toxicity) for treating bacterial infections:
Canine Skin Infections (Pyoderma): Caused by Staphylococcus pseudintermedius. Oral dose: 5–10 mg/kg body weight once daily for 7–14 days.
Canine Urinary Tract Infections: Caused by E. coli or Klebsiella spp. Oral dose: 5–10 mg/kg once daily for 7–10 days, with urine culture follow-up.
Contraindications: Never use in cats, pregnant/nursing dogs, or dogs with pre-existing renal disease or seizures (lowers seizure threshold).
Quality & Safety Assurance
As a widely used fluoroquinolone with strict efficacy and safety requirements, CAS 177325-13-2 undergoes rigorous quality control:
1. Manufacturing & Purity Control
Synthesis: Produced via chiral synthesis (to isolate the active (S)-enantiomer) or resolution of racemic ofloxacin, followed by hydrochlorination and recrystallization. Strict control over enantiomeric purity ensures (S)-enantiomer ≥99.5% (inactive (R)-enantiomer ≤0.5%).
GMP Compliance: Manufactured in Grade C/D cleanrooms (per ICH Q7 guidelines) for pharmaceutical grade, with automated processes to avoid cross-contamination and ensure batch uniformity.
2. Comprehensive Testing Protocol
| Test Item | Method | Acceptance Criterion |
|---|---|---|
| Purity & Assay | HPLC (C18 column, 293 nm detection) | Purity ≥99.0%; Assay 98.0%–102.0% |
| Enantiomeric Purity | Chiral HPLC (polysaccharide-based column) | (S)-enantiomer ≥99.5%; (R)-enantiomer ≤0.5% |
| Related Substances | HPLC (gradient elution) | Single impurity ≤0.2%; Total impurities ≤0.5% |
| Heavy Metals | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pb≤10ppm, Hg≤1ppm, Cd≤1ppm |
| Residual Solvents | GC (headspace sampling, FID detector) | Class 2 solvents ≤500ppm; Class 1 solvents not detected |
| Sterility (Injectable Grade) | Membrane filtration method | No bacterial/fungal growth |
| Dissolution Rate (Tablets) | USP Apparatus II (paddle method, pH 6.8 buffer) | ≥80% dissolved in 30 minutes |
3. Safety Reminders
Human Use:
Contraindications: Hypersensitivity to fluoroquinolones; history of tendon rupture; children <18 years (risk of articular cartilage damage); pregnancy/lactation (Category C-potential fetal risk).
Adverse Effects: Common side effects include nausea, diarrhea, and headache. Rare but serious risks: tendon rupture (especially in elderly or corticosteroid users), QT interval prolongation (avoid in patients with heart disease), and peripheral neuropathy (discontinue if numbness/tingling occurs).
Resistance Warning: Avoid overuse (e.g., for viral infections) to prevent emergence of levofloxacin-resistant strains (e.g., E. coli, K. pneumoniae).
Veterinary Use:
Withdrawal Period: Dogs (non-food animals): No withdrawal period; avoid use in food-producing animals (e.g., cattle, pigs) to prevent residue risks.
Cooperation & Contact
We supply Levofloxacin Hydrochloride in multiple grades and formulations to meet diverse needs:
Pharmaceutical Grade: Raw powder for oral tablets, capsules, and IV injections (1kg–100kg per order).
Veterinary Grade: Powder for oral canine formulations (10kg–500kg per order; monthly production capacity of 1200kg).
Value-added services include:
Providing DMF (Drug Master File) and CEP (Certificate of Suitability) for pharmaceutical-grade products to support registration in the EU, US, and Asia.
Customized processing: Micronization (for uniform dissolution in tablets) or liquid concentrates (for IV formulations).
Technical guidance: Dosage adjustments for renal impairment (human use) and resistance management strategies.
If you are a pharmaceutical manufacturer, veterinary drug enterprise, or generic drug company, please contact us for detailed cooperation:
Contact Information:
Email: sales@huarongpharma.com
Phone/WhatsApp: +86 13751168070
We adhere to the principles of "quality compliance, targeted therapy, and responsible use" and look forward to partnering with global healthcare and animal health enterprises!
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