Description

Levofloxacin Mesylate is the mesylate salt form of the broad-spectrum fluoroquinolone antibiotic, levofloxacin. This formulation is critical for enhancing the stability, solubility, and bioavailability of the active pharmaceutical ingredient in final drug products. It is an essential intermediate and active ingredient for pharmaceutical manufacturers developing sterile injectable and ophthalmic solutions. Global demand is driven by its efficacy against a wide range of bacterial infections.

Application

• Pharmaceutical API Synthesis: Primary use as an active pharmaceutical ingredient (API) in the manufacture of antibiotic formulations.
• Sterile Injectable Solutions: Key component in the production of intravenous (IV) and intramuscular (IM) antibiotic injections.
• Ophthalmic Solutions: Used in the formulation of eye drops and ointments for treating bacterial conjunctivitis and other ocular infections.
• Veterinary Pharmaceuticals: Incorporated into antibiotic treatments for bacterial infections in livestock and companion animals.
• Research & Development: Serves as a reference standard and starting material in antimicrobial research and new drug development.
• Finished Dosage Form Manufacturing: Utilized by contract manufacturing organizations (CMOs) for producing final tablet or capsule forms, though less common than injectables.

Basic Information

Product Name	Levofloxacin Mesylate
CAS No.	226578-51-4
Molecular Formula	C21H28FN3O7 • CH4O3S
Molecular Weight	541.55 g/mol
Synonyms	Levofloxacin Methanesulfonate; (-)-(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 Methanesulfonate; (S)-(-)-Ofloxacin Mesylate; Levofloxacin Mesylate Hydrate (common form); Tavanic (trade name variant); Levofloxacin Mesilate; Levofloxacin Monomethanesulfonate
EINECS	Contact for details

Quality Control

Our Levofloxacin Mesylate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) are provided, detailing parameters such as assay, related substances, residual solvents, and microbiological quality. We can supply material compliant with various pharmacopeial monographs (e.g., USP, EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
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 Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP for non-sterile substances

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