Description

Besifloxacin Hydrochloride is a synthetic fluoroquinolone antibiotic specifically designed for ophthalmic use. This compound matters for its potent and targeted bactericidal activity against a broad spectrum of Gram-positive and Gram-negative pathogens commonly associated with eye infections. It is primarily needed by pharmaceutical manufacturers and research institutions developing and producing sterile ophthalmic solutions, such as eye drops, for treating bacterial conjunctivitis.

Application

• Active Pharmaceutical Ingredient (API) in ophthalmic antibacterial formulations.
• Primary component in prescription eye drops for bacterial conjunctivitis (pink eye).
• Research and development of novel topical antibiotic treatments.
• Reference standard for analytical testing and quality control in pharmaceutical laboratories.
• Manufacturing of combination drug therapies for ocular infections.

Basic Information

Product Name	Besifloxacin Hydrochloride
CAS No.	405165-61-9
Molecular Formula	C19H21ClFN3O3•HCl
Molecular Weight	430.75 g/mol (for hydrochloride salt)
Synonyms	Besifloxacin HCl; (3R)-7-[(3R)-3-Amino-4-(2,4-diazabicyclo[4.2.0]oct-2-yl)-2-hydroxybutoxy]-9-fluoro-3-methyl-10-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid hydrochloride; BAY 73-7388; BAY-73-7388/1; SS734
EINECS	Contact for details

Quality Control

Our Besifloxacin Hydrochloride is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications, including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting compliance with relevant specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.