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Pharmaceutical Chemistry
Levofloxacin
GOST/CAS:
CAS: 138199-51-6
Levofloxacin is a highly effective antibacterial component belonging to the 3rd generation fluoroquinolone class. It appears as a white to light yellow crystalline powder, sparingly soluble in water and soluble in glacial acetic acid. It exhibits a broad spectrum of antimicrobial activity by inhibiting bacterial enzymes (DNA gyrase and topoisomerase IV), thereby disrupting the synthesis of microorganism DNA. This product is indispensable as an Active Pharmaceutical Ingredient (API) for the formulation of finished dosage vacancies such as tablets, infusion solutions, and eye drops.
Applications
Solid Dosage Form Production: Used as the primary active substance in the compression of film-coated tablets (250 mg and 500 mg dosages). It ensures stable release profiles and high bioavailability.
Injectable Solution Manufacturing: Applied in the preparation of sterile solutions for infusion. Requires strict control for endotoxins and microbiological purity during the dissolution phase.
Ophthalmology: Utilized as an active component in the production of antibacterial eye drops (0.5%) for treating superficial bacterial ocular infections.
Veterinary Medicine: Extensively used in manufacturing complex antimicrobial formulations for treating respiratory and gastrointestinal tract infections in livestock and poultry.
Key Advantages
Broad Spectrum & High Potency: Highly effective against Gram-positive and Gram-negative bacteria, including strains resistant to penicillins and cephalosporins, as well as intracellular organisms (Chlamydia, Mycoplasma).
High Chemical Purity: The substance features minimal levels of related impurities and enantiomeric isomer forms (D-isomer), guaranteeing the declared therapeutic effect while reducing toxic load.
Excellent Processability: Physical properties of the powder (bulk density and flowability) are optimized for direct compression, granulation, and rapid dissolution processes in liquid dosage forms.
Stability & Standard Compliance: Fully complies with leading pharmacopoeia standards (Ph.Eur., USP, JP), retaining its physicochemical properties perfectly under designated storage conditions.
Storage & Transportation
- Store in the original, tightly closed packaging in a dry, light-protected place out of reach of children.
- Recommended storage temperature: Not exceeding +25 °C.
- Avoid exposure to direct sunlight, moisture, and strong oxidizing agents.
- Transportation is carried out by all types of covered transport in strict compliance with temperature-sensitive cargo regulations. The product is not classified as hazardous for transport (ADR Class 9 is not applicable).
- Shelf Life: 3 years from the date of manufacture.
Technical Specifications
Appearance
White to pale yellow or cream-white crystalline powder
Molecular Weight
379.4 g/mol (for Hemihydrate)
Assay (on anhydrous basis)
≥ 98.5% to 101.0%
Melting Point
225 – 228 °C
pH (0.5% aqueous solution)
3.8 – 4.8
Specific Optical Rotation
-92° to -99°
Water Content
2.1 – 2.7% (Hemihydrate)
Supply info
- Pharmaceutical Packaging: Hermetically sealed double high-density polyethylene (HDPE) bags, packed inside 25 kg fiber drums (industry standard for APIs).
- Customized packaging sizes of 1 kg and 5 kg are available in specialized containers for pilot-scale manufacturing and laboratory use.
- Supplied with a complete documentation package: Certificate of Analysis (COA), Drug Master File (DMF), and the manufacturer's GMP certificate.