Description

Moxifloxacin Impurity 37 CAS NO 1803729-19-2 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 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: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Moxifloxacin formulations.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Moxifloxacin under various conditions.
• Quality Assurance/Quality Control (QA/QC): Acts as a primary standard for routine batch release testing to ensure product purity meets pharmacopeial specifications (e.g., USP, EP).

Basic Information

Product Name	Moxifloxacin Impurity 37
CAS No.	1803729-19-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Moxifloxacin Related Compound 37; Moxifloxacin EP Impurity 37; Moxifloxacin USP Impurity 37; 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; (1-Cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid); Moxifloxacin Process Impurity; Moxifloxacin Degradant
EINECS	Contact for details

Quality Control

Our Moxifloxacin Impurity 37 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and relevant pharmacopeial guidelines.

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 place.

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 ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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