Levofloxacin Lactate (CAS No.: 294662-18-3) - Soluble Fluoroquinolone Antibacterial for Parenteral & Oral Therapy
As a professional supplier of pharmaceutical-grade antibacterial active ingredients, we provide high-purity Levofloxacin Lactate that strictly complies with global pharmacopoeia standards (USP, EP, BP, CP). A lactate salt form of levofloxacin (the active S-enantiomer of ofloxacin), it offers enhanced water solubility compared to levofloxacin hydrochloride-making it ideal for parenteral formulations (IV injections) and oral liquid preparations. It is widely used in human medicine for treating severe bacterial infections and in select veterinary practice for companion animals, serving as a critical agent against drug-resistant pathogens.
Product Basic Information
| Item | Details |
|---|---|
| Product Name | Levofloxacin Lactate |
| CAS No. | 294662-18-3 |
| 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 lactate; Levofloxacin (lactic acid salt) |
| Molecular Formula | C₁₈H₂₀FN₃O₄·C₃H₆O₃ |
| Molecular Weight | 475.49 |
| Appearance | White to off-white crystalline powder; Odorless or with a slight lactic acid-like odor |
| Specification | - Pharmaceutical Grade: Purity ≥99.0% (HPLC); Assay (as levofloxacin) 97.0%–103.0%; Specific optical rotation [α]²⁰D -98° to -106° (in water, c=1); Loss on drying ≤1.0%; Residue on ignition ≤0.1%; Heavy metals (Pb≤10ppm, Hg≤1ppm, Cd≤1ppm); Residual solvents (methanol ≤300ppm, acetone ≤500ppm) |
| Melting Point | 185–190°C (with decomposition) |
| Solubility | Very soluble in water (≥200 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); Avoid contact with strong oxidizing agents; Shelf life: 36 months for pharmaceutical grade, 24 months for veterinary grade |
Core Functions & Mechanism of Action
Levofloxacin Lactate cas294662-18-3 exerts a bactericidal effect identical to its parent compound (levofloxacin)-the lactate salt form only enhances solubility without altering pharmacological activity. It selectively inhibits two key bacterial enzymes:
DNA gyrase (topoisomerase II): Critical for bacterial DNA supercoiling and replication.
Topoisomerase IV: Essential for chromosome segregation during bacterial cell division.
By blocking these enzymes, Levofloxacin Lactate disrupts bacterial DNA synthesis, leading to cell death. Its key advantages include:
Enhanced potency: 2–8 times more active than racemic ofloxacin against Gram-negative (e.g., Escherichia coli, Pseudomonas aeruginosa) and Gram-positive (e.g., Staphylococcus aureus, Streptococcus pneumoniae) bacteria.
Broad spectrum: Active against aerobic pathogens, atypical microbes (e.g., Mycoplasma pneumoniae, Chlamydophila pneumoniae), and mycobacteria (e.g., Mycobacterium tuberculosis).
Post-antibiotic effect (PAE): Suppresses bacterial regrowth for 2–6 hours post-dosing, enabling once-daily administration.
Core Applications
1. Human Pharmaceutical Field
Levofloxacin Lactate 294662-18-3 is primarily used for moderate-to-severe bacterial infections where rapid drug delivery (via IV) or oral liquid dosing (for children/elderly) is required. It is not indicated for viral infections (e.g., cold/flu).
1.1 Parenteral Therapy (IV Injections)
Hospital-Acquired Pneumonia (HAP): Treats HAP caused by Pseudomonas aeruginosa or methicillin-sensitive S. aureus (MSSA). IV dose: 500–750 mg (as levofloxacin) once daily for 7–14 days, adjusted for renal function.
Septicemia & Bacteremia: Used for bloodstream infections caused by drug-resistant Gram-negative bacteria (e.g., Klebsiella pneumoniae). IV dose: 750 mg once daily for 10–14 days, with transition to oral therapy once stable.
Complicated Urinary Tract Infections (cUTIs): For patients unable to take oral medications (e.g., post-surgery). IV dose: 750 mg once daily for 5 days, or 500 mg once daily for 10–14 days.
1.2 Oral Liquid Formulations
Pediatric Infections: Administered as oral suspensions for children ≥6 months with severe infections (e.g., community-acquired pneumonia). Dose: 8–10 mg/kg (as levofloxacin) once daily for 7–10 days, max 750 mg/day.
Elderly or Dysphagic Patients: Oral syrups or drops for patients with swallowing difficulties (e.g., stroke survivors) needing treatment for skin/soft tissue infections. Dose: 500–750 mg once daily for 7–10 days.
2. Veterinary Field (Companion Animals)
is approved for dogs (not cats-risk of retinal toxicity) for treating bacterial infections, with a focus on injectable formulations for severe cases:
Canine Pyoderma (Skin Infections): Caused by Staphylococcus pseudintermedius. IV/oral dose: 5–10 mg/kg (as levofloxacin) once daily for 7–14 days.
Canine Respiratory Infections: For kennel cough (caused by Bordetella bronchiseptica + bacterial co-infection). IV dose: 7.5 mg/kg once daily for 5–7 days, followed by oral maintenance.
Contraindications: Never use in cats, pregnant/nursing dogs, or dogs with renal impairment, seizures, or retinal disease.
Quality & Safety Assurance
As a soluble fluoroquinolone for critical care, cas294662-18-3 undergoes strict quality control to ensure efficacy, solubility, and safety:
1. Manufacturing & Purity Control
Synthesis: Produced by reacting levofloxacin free base with lactic acid in aqueous solution, followed by crystallization. The process is optimized to ensure:
High solubility: Lactate salt form achieves ≥200 g/L solubility in water (vs. ~100 g/L for hydrochloride), critical for IV formulations.
Enantiomeric purity: (S)-enantiomer ≥99.5% (inactive (R)-enantiomer ≤0.5%), ensuring potency.
GMP Compliance: Manufactured in Grade C cleanrooms (per ICH Q7 guidelines) for injectable-grade raw materials, with strict control over endotoxin levels (≤0.25 EU/mL for IV use).
2. Comprehensive Testing Protocol
| Test Item | Method | Acceptance Criterion |
|---|---|---|
| Purity & Assay | HPLC (C18 column, 293 nm detection) | Purity ≥99.0%; Assay 97.0%–103.0% (as levofloxacin) |
| Enantiomeric Purity | Chiral HPLC (polysaccharide 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 |
| Endotoxin (Injectable Grade) | LAL (Limulus Amebocyte Lysate) Test | ≤0.25 EU/mL |
| Solubility Test | Gravimetric method (25°C, water) | ≥200 g/L, clear solution (no turbidity) |
3. Safety Reminders
Human Use:
Contraindications: Hypersensitivity to fluoroquinolones; history of tendon rupture; children <6 months; pregnancy/lactation (Category C).
Adverse Effects: Common: nausea, diarrhea, headache. Rare but serious: tendon rupture (elderly/corticosteroid users), QT prolongation (heart disease patients), peripheral neuropathy.
Resistance Warning: Avoid overuse (e.g., for mild infections) to prevent resistant strains (e.g., E. coli, Acinetobacter baumannii).
Veterinary Use:
Withdrawal Period: Dogs (non-food animals): No withdrawal period; prohibited in food-producing animals (e.g., cattle, pigs) to avoid residue risks.
Cooperation & Contact
We supply Levofloxacin Lactate in grades tailored to parenteral and oral applications:
Pharmaceutical Grade (Injectable): Fine powder for IV formulations (1kg–100kg per order, amber glass vials with nitrogen protection).
Pharmaceutical Grade (Oral): Granules for oral suspensions (10kg–500kg per order; monthly production capacity of 1500kg).
Veterinary Grade: Powder for canine injectables/oral liquids (5kg–200kg per order).
Value-added services include:
Providing DMF (Drug Master File) and CEP (Certificate of Suitability) for pharmaceutical-grade products to support EU/US/Asia registration.
Customized solubility optimization (e.g., for high-concentration IV solutions) and impurity profiling.
Technical guidance: Renal dose adjustment (human use) and veterinary formulation stability testing.
If you are a pharmaceutical manufacturer, generic drug company, or veterinary drug enterprise, please contact us for detailed cooperation:
Contact Information:
Email: sales@huarongpharma.com
Phone/WhatsApp: +86 13751168070
We adhere to the principles of "quality compliance, solubility excellence, and responsible therapy" and look forward to partnering with global healthcare and animal health industries!
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