Description

Levofloxacin Hemihydrate is a synthetic broad-spectrum fluoroquinolone antibiotic, representing the pharmacologically active L-isomer of ofloxacin. It is a critical active pharmaceutical ingredient (API) valued for its potent activity against a wide range of Gram-positive and Gram-negative bacteria. This high-purity compound is essential for pharmaceutical manufacturers developing and producing solid and liquid dosage forms, such as tablets, injections, and ophthalmic solutions, to treat serious bacterial infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of antibiotic medications.
• Tablet Manufacturing: Used in the production of oral tablets for systemic antibacterial therapy.
• Injectable Solutions: Formulated into sterile intravenous or intramuscular injections for hospital use.
• Ophthalmic Preparations: Incorporated into eye drops and ointments for treating bacterial conjunctivitis and corneal ulcers.
• Respiratory Infection Treatments: A key component in medications for pneumonia, bronchitis, and sinusitis.
• Urinary Tract Infection (UTI) Medications: Used in drugs targeting complicated and uncomplicated UTIs.
• Skin and Soft Tissue Infection Drugs: Formulated into treatments for bacterial cellulitis and wound infections.
• Research & Development: Serves as a reference standard and raw material in pharmaceutical R&D labs for new drug development and analytical studies.

Basic Information

Item	Detail
Product Name	Levofloxacin Hemihydrate
CAS No.	138199-71-0
Molecular Formula	C18H20FN3O4 · ½ H2O
Molecular Weight	370.38 g/mol (hemihydrate)
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 hemihydrate; Levofloxacin Sesquihydrate; (S)-(-)-Ofloxacin; Tavanic (brand name); Levaquin (brand name); LVFX; DR-3355
EINECS	Contact for details

Quality Control

Our Levofloxacin Hemihydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use, typically conforming to USP, EP, and JP monographs. Key parameters including assay, optical rotation, related substances, residual solvents, and microbial limits are rigorously controlled. A Certificate of Analysis (COA) documenting all test results is provided with every shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The original container should be kept sealed when not in use.

Specification

Item	Specification
Appearance	White to slightly yellow crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC, anhydrous basis)	98.5% - 101.0%
Specific Optical Rotation	-92° to -98°
pH (1% suspension)	6.5 - 7.5
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	1.5% - 2.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP

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