Levofloxacin

Levofloxacin

Parameter Specification
Product Name Levofloxacin
CAS Number 100986-85-4
Molecular Formula C18H20FN3O4
Molecular Weight 361.37 g/mol
Appearance White to off-white crystalline powder
Assay (HPLC) 98.5% – 101.0% (on dried basis)
Solubility Slightly soluble in water; soluble in acetic acid; practically insoluble in ethanol
Package 25 kg fiber drum with double polyethylene liner

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Levofloxacin Structure

Synonyms: Levofloxacin, Levaquin, Cravit, Tavanic, Quixin, Ofloxacin S-(-)-isomer

Levofloxacin has become a staple in the global API market, driven by its broad-spectrum efficacy and favorable safety profile. As a third-generation fluoroquinolone, it is widely used in both oral and intravenous formulations for respiratory, urinary, and skin infections. Demand remains strong, particularly in Asia and Latin America, where generic penetration is high and healthcare access is expanding.

Chemically, levofloxacin is the levo-isomer of ofloxacin, belonging to the fluoroquinolone class. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication. This mechanism gives it bactericidal activity against a wide range of Gram-negative and Gram-positive pathogens.

Our levofloxacin is manufactured under strict GMP conditions and is available in high purity, meeting pharmacopeial standards including USP, EP, and BP. It is supplied as a white to off-white crystalline powder, suitable for tablet, capsule, and sterile injectable production.

Function & Mechanism

  • DNA gyrase inhibition: Blocks bacterial DNA replication, leading to cell death.
  • Topoisomerase IV inhibition: Disrupts chromosome partitioning during cell division.
  • Broad-spectrum activity: Effective against Gram-negative and Gram-positive bacteria, including atypical pathogens.
  • Concentration-dependent killing: Exhibits rapid bactericidal effect at higher concentrations.

Source & Standardization

  • Source: Synthetic fluoroquinolone
  • Manufacturing: Multi-step chemical synthesis, followed by purification and crystallization
  • Standardization: Complies with USP/EP/BP monographs
  • Forms: Crystalline powder
  • Applications: Oral solid dosage forms, sterile injectables, ophthalmic solutions

Quality Specifications (QC Tests)

Test Item Specification
Identification IR, HPLC retention time matches standard
Loss on Drying ≤ 0.5%
Residue on Ignition ≤ 0.1%
Heavy Metals ≤ 20 ppm
Organic Impurities Meets USP/EP requirements
Microbial Limits Total aerobic count ≤ 1000 CFU/g; absence of specified pathogens

Bulk Supply & Documentation

  • Packaging: 25 kg fiber drum with double polyethylene liner
  • MOQ: 1 kg
  • Lead time: 3-5 business days (stock items)
  • Documentation: COA, MSDS, TDS available upon request

Frequently Asked Questions

What is the minimum order quantity (MOQ)?

Our MOQ is 1 kg for stock items.

What is the delivery time?

For stock items, delivery is 3-5 business days after order confirmation.

Do you provide COA and samples?

Yes, we provide COA, MSDS, and TDS. Samples are available upon request.

How is the product packaged?

It is packed in 25 kg fiber drums with double polyethylene liners.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

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