Description

Trazodone Impurity H is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of related substances in Trazodone hydrochloride active pharmaceutical ingredient (API) and finished drug products. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on method development, validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for identifying and quantifying Trazodone Impurity H in drug substance and drug product analysis.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Quality Control and Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity levels and ensure product safety and shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control of impurities as per ICH Q3A(R2) and Q3B(R2) requirements.
• Pharmacopoeial Testing: Used for testing against monographs in USP, EP, or other pharmacopoeias where this impurity is specified.
• Research and Development: Supports synthetic chemistry research, metabolic studies, and the investigation of degradation pathways for Trazodone.

Basic Information

Product Name	Trazodone Impurity H
CAS No.	6323-09-7
Molecular Formula	C19H22ClN5O
Molecular Weight	371.86 g/mol
Synonyms	1-{3-[4-(3-Chlorophenyl)-1-piperazinyl]propyl}-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one; Trazodone Related Compound H; 1,2,4-Triazolo[4,3-a]pyridin-3(2H)-one, 1-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-; UNII-6Y1V7J4Q3F; 6Y1V7J4Q3F; Trazodone Impurity 7; Trazodone EP Impurity H
EINECS	Contact for details

Quality Control

Our Trazodone Impurity H is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of specific impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications and supporting its use as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

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

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