Description

Moxifloxacin Impurity 29 CAS NO 1620445-12-6 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 an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Moxifloxacin API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating stability-indicating assay methods for Moxifloxacin.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency according to ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identity and control strategies.
• Stability Studies: Used to track the formation of degradation products during forced degradation and long-term stability studies of Moxifloxacin formulations.
• Research & Development: Facilitates research into the synthesis pathways, degradation mechanisms, and pharmacokinetics of Moxifloxacin and related fluoroquinolone antibiotics.

Basic Information

Product Name	Moxifloxacin Impurity 29
CAS No.	1620445-12-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Moxifloxacin Related Compound 29; Moxifloxacin EP Impurity J; Moxifloxacin Process 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; Fluoroquinolone Impurity; Antibiotic Impurity Standard; Avelox Impurity.
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 29 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results for all specified parameters. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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 impurity ≤ 1.0%; Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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