Description

Trazodone Impurity 3/Trazodone Bromo Analog/2-{3-[4-(3-Bromophenyl)Piperazin-1-Yl]Propyl}-[1,2,4]Triazolo[4,3-A]Pyridin-3(2H)-One is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker for the quality control and regulatory compliance of the antidepressant drug Trazodone HCl. It is essential for analytical chemists and quality assurance professionals in pharmaceutical companies and contract research organizations (CROs) who require reliable standards for method development, validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification in Trazodone HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS techniques in quality control laboratories.
• Stability Indicating Method (SIM) Studies to monitor degradation pathways and establish shelf-life for Trazodone-based medications.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and other global health authorities.
• Pharmacopoeial Testing as a certified reference material for testing against USP, EP, or other pharmacopoeia monographs.
• Research and Development of generic Trazodone formulations, ensuring impurity thresholds meet ICH Q3A/B guidelines.
• Calibration and Qualification of analytical instruments using a traceable and well-characterized standard.

Basic Information

Item	Details
Product Name	Trazodone Impurity 3/Trazodone Bromo Analog/2-{3-[4-(3-Bromophenyl)Piperazin-1-Yl]Propyl}-[1,2,4]Triazolo[4,3-A]Pyridin-3(2H)-One
CAS No.	1263358-13-9
Molecular Formula	C23H26BrN5O
Molecular Weight	468.39 g/mol
Synonyms	Trazodone Bromo Analog; Trazodone Impurity 3; 2-[3-[4-(3-Bromophenyl)piperazin-1-yl]propyl]-[1,2,4]triazolo[4,3-a]pyridin-3-one; 2-{3-[4-(3-Bromophenyl)-1-piperazinyl]propyl}[1,2,4]triazolo[4,3-a]pyridin-3(2H)-one; UNII-9XK6K7T8QN; 9XK6K7T8QN; Trazodone Related Compound C (Bromo Analog)
EINECS	Contact for details

Quality Control

Every batch of our Trazodone Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with ICH Q3A, Q3B, and relevant pharmacopoeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, related substances, residual solvents, and other critical tests. Our commitment to traceability and data integrity supports your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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