Description

Trazodone Impurity Qzt-Im-2-Z2 (Impurity Z) Hydrochloride is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antidepressant drug Trazodone HCl. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Impurity Z in Trazodone Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control laboratories to monitor and control impurity levels during API synthesis and drug product manufacturing to meet pharmacopeial specifications (USP, EP).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, justify specifications, and demonstrate comprehensive control of the drug substance.
• Stability Studies: Employed as a marker to track the formation of degradation products in Trazodone formulations under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Used in synthetic chemistry R&D to study impurity formation pathways and to develop improved purification processes for Trazodone API.

Basic Information

Product Name	Trazodone Impurity Qzt-Im-2-Z2 (Impurity Z) Hydrochloride
CAS No.	328410-01-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trazodone Impurity Z; Trazodone Related Compound Z; 2-[3-[4-(3-Chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one Hydrochloride; Trazodone EP Impurity Z; Trazodone Hydrochloride Impurity Z; Qzt-Im-2-Z2; Impurity Z of Trazodone HCl
EINECS	Contact for details

Quality Control

Every batch of Trazodone Impurity Qzt-Im-2-Z2 (Impurity Z) Hydrochloride is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.