Description

Trazodone n-Oxide CAS NO 55290-68-1 is a significant pharmaceutical intermediate and metabolite of the antidepressant drug Trazodone. Its primary value lies in its critical role in pharmaceutical research and development, particularly for metabolism studies, impurity profiling, and analytical reference standards. This compound is essential for organizations focused on drug safety, quality control, and the development of generic pharmaceuticals. Key users include pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in advanced chemical synthesis and regulatory compliance work.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Trazodone and its related substances in drug products and active pharmaceutical ingredients (APIs).
• Metabolite Studies: Used in pharmacokinetic and pharmacodynamic research to understand the metabolic pathways and biological activity of Trazodone.
• Impurity Profiling: Critical for the identification, characterization, and control of process-related impurities and degradation products in Trazodone API manufacturing, ensuring compliance with ICH guidelines.
• Analytical Method Development: Employed as a key component in developing and validating HPLC, LC-MS, and other chromatographic methods for pharmaceutical analysis.
• Chemical Synthesis Intermediate: Utilized in the research-scale synthesis of novel Trazodone analogs or for studying structure-activity relationships (SAR).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for ANDA, NDA) by providing definitive characterization data for drug substances.

Basic Information

Product Name	Trazodone n-Oxide
CAS No.	55290-68-1
Molecular Formula	C19H22ClN5O2
Molecular Weight	387.86 g/mol
Synonyms	2-[3-[4-(3-Chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one 1-Oxide; Trazodone N-Oxide; Trazodone 1-Oxide; Trazodone Metabolite m4; 1-{3-[4-(3-Chlorophenyl)piperazin-1-yl]propyl}-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one 1-Oxide
EINECS	Contact for details

Quality Control

Our Trazodone n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of specific impurities. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results for all critical parameters. Our quality commitment aligns with the standards expected for pharmaceutical reference materials and advanced intermediates.

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 desiccated conditions.

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)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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