Description

Balofloxacin Dihydrate CAS NO 151060-21-8 is a synthetic fluoroquinolone antibiotic compound, valued for its potent antibacterial activity against a broad spectrum of Gram-positive and Gram-negative pathogens. It serves as a critical active pharmaceutical ingredient (API) in the development and formulation of advanced antibacterial medications. This product is essential for pharmaceutical manufacturers and research institutions focused on creating treatments for respiratory, urinary tract, and other systemic bacterial infections.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the synthesis of antibacterial drugs.
• Formulation of oral dosage forms such as tablets and capsules for systemic antibiotic therapy.
• Research and development of novel fluoroquinolone-based therapeutics in pharmaceutical R&D laboratories.
• Production of veterinary medicinal products for treating bacterial infections in animals.
• Reference standard for quality control and analytical testing in pharmaceutical manufacturing.
• Intermediate in the synthesis of more complex antimicrobial agents.

Basic Information

Product Name	Balofloxacin Dihydrate
CAS No.	151060-21-8
Molecular Formula	C20H24FN3O4 · 2H2O
Molecular Weight	419.43 g/mol (Dihydrate)
Synonyms	Balofloxacin Hydrate; Q-35; Q-35 (antibiotic); 1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methylaminopiperidin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid dihydrate; (±)-Balofloxacin Dihydrate; Balofloxacin Dihydrate (USAN); Balofloxacin (USAN) Dihydrate; 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methylamino-1-piperidinyl)-4-oxo-3-quinolinecarboxylic acid dihydrate
EINECS	Contact for details

Quality Control

Our Balofloxacin Dihydrate is manufactured under strict quality management systems. The product undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles. We adhere to cGMP principles to ensure consistent quality and traceability for our global clientele.

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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	7.5% - 9.5%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Limits	Complies with Ph. Eur./USP

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