Description

8-Fluoro-6-Methoxy Moxifloxacin Dihydrochloride is a high-purity pharmaceutical intermediate and reference standard critical for the development and quality control of advanced fluoroquinolone antibiotics. This compound serves as a key building block in the synthesis of Moxifloxacin, a broad-spectrum antibacterial agent used to treat serious infections. It is essential for research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in API production, method validation, and regulatory compliance.

Application

• Pharmaceutical Intermediate: Primary raw material for the synthesis of the active pharmaceutical ingredient (API) Moxifloxacin Hydrochloride.
• Analytical Reference Standard: Used in HPLC, LC-MS, and other chromatographic methods for the identification, assay, and impurity profiling of Moxifloxacin in drug substances and finished products.
• Process Research & Development (R&D): Employed in route scouting, process optimization, and scale-up studies for antibiotic manufacturing.
• Quality Control & Assurance: Serves as a critical standard in in-house QC laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial monographs (USP, EP, BP).
• Metabolite and Impurity Studies: Used in research to identify, synthesize, and quantify degradation products and process-related impurities.
• Regulatory Submissions: Provides certified material for generating data required for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).

Basic Information

Product Name	8-Fluoro-6-Methoxy Moxifloxacin Dihydrochloride
CAS No.	1029364-77-9
Molecular Formula	C21H25Cl2FN3O4
Molecular Weight	482.35 g/mol
Synonyms	Moxifloxacin Dihydrochloride Impurity; 1-Cyclopropyl-8-fluoro-6-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid dihydrochloride; 8-Fluoro-6-Methoxy Moxifloxacin 2HCl; BAY 12-8039 Dihydrochloride; Moxifloxacin Related Compound Dihydrochloride; Avelox Intermediate Dihydrochloride
EINECS	Contact for details

Quality Control

Our 8-Fluoro-6-Methoxy Moxifloxacin Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and impurity profiles, suitable for use as a reference standard and pharmaceutical intermediate. Certificates of Analysis (COA) detailing results from HPLC, NMR, and MS are provided with each shipment. We support compliance with cGMP, ICH Q7, and major pharmacopeial guidelines.

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 under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or a nitrogen atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤2.0%

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