Description

Moxifloxacin Impurity 67 CAS NO 1430075-14-1 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 Moxifloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Moxifloxacin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control testing to ensure Moxifloxacin batches meet pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Research & Development: Used in synthetic chemistry and metabolic studies to understand the degradation pathways of Moxifloxacin.

Basic Information

Product Name	Moxifloxacin Impurity 67
CAS No.	1430075-14-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	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; Moxifloxacin Related Compound; Moxifloxacin EP Impurity; Moxifloxacin USP Impurity; 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; BA 31112-07; UNII-9QH6S8E2JN
EINECS	Contact for details

Quality Control

Our Moxifloxacin Impurity 67 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure high purity and structural identity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting compliance with ICH guidelines and pharmacopeial standards for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Water Content (KF)	≤ 2.0%
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.