Description

Moxifloxacin Impurity 30 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 hydrochloride. 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, and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in moxifloxacin formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (USP, EP, BP) that specify impurity limits for moxifloxacin.
• Research & Development: Used in R&D to study the synthesis pathways, degradation mechanisms, and metabolic pathways related to moxifloxacin.

Basic Information

Product Name	Moxifloxacin Impurity 30
CAS No.	1395056-42-4
Molecular Formula	C21H24FN3O4
Molecular Weight	401.43 g/mol
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 30; Moxifloxacin EP Impurity I; Moxifloxacin USP Impurity; Avelox Impurity 30; BAY 12-8039 Impurity 30
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 30 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopoeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% 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.