Description

Fluvoxamine Ep Impurity B Maleate is a high-purity reference standard specifically used in the analytical profiling of the antidepressant fluvoxamine. This compound is critical for pharmaceutical quality control and regulatory compliance, enabling the accurate identification and quantification of a key process-related impurity. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, stability studies, and ensuring drug safety and efficacy according to pharmacopeial standards such as EP and USP.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Fluvoxamine Maleate impurities.
• Analytical Method Development and Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits.
• Quality Control and Assurance (QC/QA): Essential for batch release testing of Fluvoxamine Active Pharmaceutical Ingredient (API) and finished dosage forms to ensure compliance with ICH guidelines.
• Stability Studies: Employed to monitor impurity profiles and degradation pathways of Fluvoxamine under various stress conditions.
• Pharmacopeial Testing: Supports testing procedures mandated by the European Pharmacopoeia (EP) and United States Pharmacopeia (USP) for impurity control.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings.

Basic Information

Product Name	Fluvoxamine Ep Impurity B Maleate
CAS No.	89035-92-7
Molecular Formula	C19H23F3N2O2 • C4H4O4
Molecular Weight	516.48 g/mol
Synonyms	Fluvoxamine Impurity B Maleate; 5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone O-(2-Aminoethyl)oxime Maleate; Fluvoxamine Related Compound B Maleate; (E)-5-Methoxy-1-[4-(trifluoromethyl)phenyl]pentan-1-one O-[(2-aminoethyl)oxime] Maleate; Fluvoxamine EP Impurity B; Fluvoxamine Maleate Impurity B
EINECS	Contact for details

Quality Control

Every batch of Fluvoxamine Ep Impurity B Maleate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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