Description

Ofloxacin Hydrochloride is a synthetic fluoroquinolone antibiotic compound, widely recognized for its potent antibacterial activity. Its primary value lies in its role as a key pharmaceutical intermediate for the synthesis of active pharmaceutical ingredients (APIs) targeting a broad spectrum of bacterial infections. This high-purity chemical is essential for manufacturers in the pharmaceutical industry, particularly those developing and producing antibiotic formulations, ophthalmic solutions, and veterinary medicines. Consistent quality and reliable supply are critical for ensuring the efficacy and safety of the final drug products.

Application

• Pharmaceutical API Synthesis: Primary use as a critical intermediate in the manufacture of Ofloxacin and its derivative antibiotic APIs.
• Antibacterial Formulations: Used in the production of finished dosage forms such as tablets, capsules, and injectables for human medicine.
• Ophthalmic Preparations: Key ingredient in the formulation of eye drops and ointments for treating bacterial eye infections.
• Veterinary Pharmaceuticals: Employed in creating antibacterial treatments for livestock and companion animals.
• Research & Development: Serves as a reference standard and starting material in microbiological and pharmacological research.
• Bulk Drug Substance: Supplied to contract manufacturing organizations (CMOs) for large-scale drug production under GMP guidelines.

Basic Information

Product Name	Ofloxacin Hydrochloride
CAS No.	118120-51-7
Molecular Formula	C18H20FN3O4 • HCl
Molecular Weight	397.83 g/mol
Synonyms	Ofloxacin HCl; (±)-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; Ofloxacin monohydrochloride; DL-8280 Hydrochloride; HOE 280 Hydrochloride; (±)-Ofloxacin hydrochloride; 9-Fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid hydrochloride
EINECS	Contact for details

Quality Control

Our Ofloxacin Hydrochloride is manufactured and tested to meet stringent quality standards suitable for pharmaceutical applications. We offer material compliant with pharmacopeial specifications such as USP, EP, and JP. Every batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, residual solvent analysis, and microbiological examination. A Certificate of Analysis (COA) documenting all test results is provided with each shipment to ensure full traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to prevent degradation and clumping.

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)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm
Microbial Limits	Conforms to EP/USP criteria

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