Description

Moxifloxacin Impurity 20 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Moxifloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in antibiotic production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Moxifloxacin API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels during API synthesis and purification.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (light, heat, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic studies, pharmacokinetic research, and to understand the degradation pathways of Moxifloxacin.

Basic Information

Product Name	Moxifloxacin Impurity 20 Hcl
CAS No.	959347-97-8
Molecular Formula	C21H24FN3O4 • HCl
Molecular Weight	437.90 g/mol (Free base: 401.44 g/mol)
Synonyms	Moxifloxacin Related Compound 20 Hcl; Moxifloxacin Impurity 20 Hydrochloride; 1-Cyclopropyl-7-[(2S,4S)-2,8-diazabicyclo[4.3.0]nonan-8-yl]-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride; Moxifloxacin EP Impurity 20 Hcl; Moxifloxacin USP Impurity 20 Hcl; Avelox Impurity 20 Hcl; BAY 12-8039 Impurity 20 Hcl
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 20 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, preferably between 15°C and 25°C. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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