Description

Levofloxacin Hydroxy Acid CAS NO 1036016-10-0 is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of the fluoroquinolone antibiotic Levofloxacin. Its primary value lies in ensuring the purity, safety, and regulatory compliance of the final active pharmaceutical ingredient (API). This compound is essential for manufacturers and analytical laboratories in the pharmaceutical industry focused on antibiotic production and rigorous impurity profiling.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of the antibiotic Levofloxacin.
• Reference Standard: Used as a certified impurity standard for HPLC and other analytical methods to quantify related substances in Levofloxacin API.
• Quality Control & R&D: Essential for method development, validation, and stability studies in pharmaceutical quality assurance laboratories.
• Regulatory Compliance: Supports the generation of impurity data required for regulatory filings (e.g., FDA, EMA) for Levofloxacin-based drug products.
• Metabolite Studies: Used in research to study the degradation pathways and metabolism of Levofloxacin.

Basic Information

Product Name	Levofloxacin Hydroxy Acid
CAS No.	1036016-10-0
Molecular Formula	C18H20FN3O5
Molecular Weight	377.37 g/mol
Synonyms	(3S)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic Acid; Levofloxacin Impurity; Levofloxacin Related Compound; (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 Hydroxy Impurity; Levofloxacin Carboxylic Acid Metabolite
EINECS	Contact for details

Quality Control

Our Levofloxacin Hydroxy Acid is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specified purity grades.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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