Description

Moxifloxacin Impurity 23 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. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical 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 and control impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemistry of Moxifloxacin.

Basic Information

Product Name	Moxifloxacin Impurity 23
CAS No.	855661-74-4
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 EP Impurity J; Moxifloxacin Related Compound J; Moxifloxacin USP Related Compound J; Avelox Impurity J; Octahydropyrrolopyridine Moxifloxacin Impurity
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 23 is manufactured and analyzed under strict quality management systems. The product is characterized using advanced spectroscopic and chromatographic techniques (including HPLC, LC-MS, NMR, and IR) to confirm identity and ensure high purity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, impurity profile, and analytical results. Our quality standards align with pharmacopeial requirements for reference standards.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere or in a desiccator.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.2%

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