Description

Moxifloxacin Impurity 8 is a specified impurity and reference standard used in the analytical profiling of the antibiotic Moxifloxacin. This compound is critical for pharmaceutical research and development, enabling the identification, quantification, and control of impurities to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality assurance and compliance testing of Moxifloxacin API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Moxifloxacin and its related substances.
• Method Development and Validation: Essential for developing and validating robust HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control the level of this specific impurity in active pharmaceutical ingredient (API) batches.
• Stability Studies: Employed to track the formation of degradation products in Moxifloxacin formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports testing in compliance with monographs from USP, EP, BP, or other international pharmacopoeias.

Basic Information

Product Name	Moxifloxacin Impurity 8
CAS No.	1829588-19-3
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 8; Moxifloxacin EP Impurity I; Moxifloxacin USP Impurity; Avelox Impurity 8; BAY 12-8039 Impurity 8; (4aS,7aS)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-3-quinolinecarboxylic acid
EINECS	Contact for details

Quality Control

Our Moxifloxacin Impurity 8 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis to ensure compliance with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming the product meets specifications for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
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.