Description

Moxifloxacin Related Compound A (Hcl Salt Form) is a high-purity chemical reference standard, essential for analytical and quality control processes in pharmaceutical development. This compound, with CAS No. 151282-23-4, serves as a critical impurity marker for ensuring the safety and efficacy of the fluoroquinolone antibiotic, Moxifloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Moxifloxacin Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: A critical component for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Moxifloxacin.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global regulatory requirements.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies related to fluoroquinolone antibiotics.

Basic Information

Product Name	Moxifloxacin Related Compound A (Hcl Salt Form)
CAS No.	151282-23-4
Molecular Formula	C21H25FN3O4 • HCl
Molecular Weight	437.90 g/mol (Free base: 402.45 g/mol)
Synonyms	1-Cyclopropyl-7-[(1S,6S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride; Moxifloxacin Impurity A HCl; Moxifloxacin EP Impurity A HCl; Moxifloxacin Hydrochloride Related Compound A; 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid hydrochloride; Avelox Related Compound A (HCl Salt); BAY 12-8039 Related Compound A HCl
EINECS	Contact for details

Quality Control

Our Moxifloxacin Related Compound A (Hcl Salt Form) is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, in alignment with ICH Q3A/B guidelines. A detailed Certificate of Analysis (COA) providing batch-specific results is supplied with every shipment.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.