Description

Moxifloxacin Impurity 34 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 research institutions 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 of Moxifloxacin to monitor impurity profiles over time.
• 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 R&D laboratories to study the formation, fate, and chemical behavior of this impurity during the synthesis of Moxifloxacin.
• Pharmacopoeial Testing: Serves as a reference material for testing against pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for known and unknown impurities.

Basic Information

Product Name	Moxifloxacin Impurity 34
CAS No.	1824286-08-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-cyclopropyl-6-fluoro-7-[(4aS,7aS)-hexahydropyrrolo[3,4-b]pyridin-6(1H)-yl]-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Moxifloxacin Related Compound 34; Moxifloxacin EP Impurity G; Moxifloxacin USP Impurity; Moxifloxacin Process Impurity; Avelox Impurity
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 34 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques (HPLC, LC-MS) to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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