Description

Moxifloxacin Impurity 27 CAS NO 1510839-91-4 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 quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards in antibiotic production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Moxifloxacin API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Common Technical Documents (CTD), and submissions to agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation of degradation products in Moxifloxacin formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Moxifloxacin Impurity 27
CAS No.	1510839-91-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Moxifloxacin Related Compound 27; 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 impurity; Avelox Impurity 27; BAY 12-8039 Impurity 27
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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