Description

Moxifloxacin Impurity 29 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 quality control testing. The product is supplied with comprehensive analytical data to support its use in regulated environments.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of moxifloxacin API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and understand degradation pathways of moxifloxacin.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing a characterized impurity for identification and qualification.
• Research & Development: Used in pharmaceutical R&D to study the synthesis, formation, and control of process-related impurities.
• Pharmacopoeial Testing: Serves as a reference material for testing against pharmacopoeial monographs (e.g., USP, EP, BP) for moxifloxacin.

Basic Information

Product Name	Moxifloxacin Impurity 29
CAS No.	1395056-41-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Moxifloxacin Related Compound 29; Moxifloxacin EP Impurity J; Moxifloxacin USP Impurity; 1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid impurity; Avelox Impurity 29; BAY 12-8039 Impurity 29
EINECS	Contact for details

Quality Control

Our Moxifloxacin Impurity 29 is manufactured under strict quality control conditions. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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