Description

Levofloxacin Hydrochloride CAS NO 177325-13-2 is the hydrochloride salt of Levofloxacin, the pure L-isomer of the fluoroquinolone antibiotic ofloxacin. This compound is a critical active pharmaceutical ingredient (API) valued for its enhanced potency and broad-spectrum antibacterial activity against a wide range of Gram-positive and Gram-negative pathogens. It is essential for pharmaceutical manufacturers developing sterile injectable formulations, oral tablets, and ophthalmic solutions. The high-purity grade is fundamental for ensuring the efficacy, safety, and regulatory compliance of finished antibiotic medications.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antibiotic drugs.
• Injectable Formulations: Production of sterile intravenous (IV) and intramuscular (IM) solutions for systemic infections.
• Oral Solid Dosage Forms: Key component in tablets and capsules for oral administration.
• Ophthalmic Solutions: Used in eye drops and ointments for treating bacterial conjunctivitis and corneal ulcers.
• Veterinary Pharmaceuticals: Formulation of antibacterial treatments for companion and livestock animals.
• Research & Development: Serves as a reference standard and starting material in pharmacological and microbiological studies.

Basic Information

Product Name	Levofloxacin Hydrochloride
CAS No.	177325-13-2
Molecular Formula	C18H20FN3O4 • HCl • H2O
Molecular Weight	415.83 g/mol (as monohydrate)
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 hydrochloride hydrate; Levofloxacin HCl; Levofloxacin Hydrochloride Hydrate; (S)-(-)-Ofloxacin Hydrochloride; Tavanic (as API); Levaquin (as API); LVFX HCl
EINECS	Contact for details

Quality Control

Our Levofloxacin Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity pharmacopeial standards, including USP, EP, and CP monographs. Key parameters such as assay, enantiomeric purity, related substances, residual solvents, and microbiological load are rigorously controlled. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to slightly yellow crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC, anhydrous basis)	98.5% - 101.5%
Specific Optical Rotation	-94.0° to -99.0°
pH (1% Solution)	3.5 - 5.0
Related Substances (HPLC)	Individual Impurity: ≤ 0.2% Total Impurities: ≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C Guidelines
Water Content (KF)	3.0% - 6.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 0.25 EU/mg (for injectable grade)
Microbial Enumeration	Meets EP/USP criteria

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