Description

Trazodone Impurity Qzt-Im-2-Z3 Hydrochloride is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the antidepressant drug Trazodone by enabling precise identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The material is supplied with comprehensive analytical data to support method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of impurities in Trazodone Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure Trazodone batches meet pharmacopeial (USP, EP, BP) specifications for related substances.
• Stability Studies: Used to track the formation of degradation products in Trazodone formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Supports impurity profiling and route scouting during the synthesis and process optimization of Trazodone.

Basic Information

Product Name	Trazodone Impurity Qzt-Im-2-Z3 Hydrochloride
CAS No.	79145-33-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trazodone Related Compound Z3 Hydrochloride; Trazodone Impurity Z3 HCl; Qzt-Im-2-Z3 Hydrochloride; Trazodone Process Impurity Hydrochloride; Trazodone Specified Impurity; 2-[3-[4-(3-Chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one Hydrochloride (Tentative); Trazodone Hydrochloride Impurity Z3
EINECS	Contact for details

Quality Control

Every batch of Trazodone Impurity Qzt-Im-2-Z3 Hydrochloride is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing results for assay, 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). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Maximum Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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