Description

Moxifloxacin Impurity 68 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of specific impurities during the development and manufacturing of the antibiotic Moxifloxacin. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method validation, stability studies, and regulatory compliance for fluoroquinolone antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Moxifloxacin and related substances.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in in-process testing and final product release to ensure Moxifloxacin API and drug products meet stringent pharmacopeial purity specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and synthesis of Moxifloxacin and its analogs.

Basic Information

Product Name	Moxifloxacin Impurity 68
CAS No.	2085709-73-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Moxifloxacin Related Compound 68; Moxifloxacin EP Impurity I; 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; (1S,6S)-7-(6-Fluoro-8-methoxy-1-cyclopropyl-4-oxo-1,4-dihydroquinoline-3-carbonyl)-2,7-diazabicyclo[4.2.0]octan-8-one; Avelox Impurity 68; Moxifloxacin Degradant
EINECS	Contact for details

Quality Control

Our Moxifloxacin Impurity 68 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm compliance with in-house specifications aligned with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for assay, purity, and related substances is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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