Description

Trazodone Isobutyl Ether Impurity Hcl is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the analysis and quality control of the antidepressant drug Trazodone, ensuring product safety and regulatory compliance. It is essential for analytical chemists and quality assurance professionals in pharmaceutical manufacturing and contract research organizations (CROs) who require precise standards for method validation and impurity profiling.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Trazodone Hydrochloride API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Trazodone.
• Essential for pharmaceutical quality control laboratories to establish specification limits and ensure batch-to-batch consistency.
• Valuable for regulatory submissions (e.g., to FDA, EMA) requiring detailed impurity characterization data.
• Supports academic and institutional research focused on the metabolism, pharmacokinetics, and synthesis of Trazodone.

Basic Information

Product Name	Trazodone Isobutyl Ether Impurity Hcl
CAS No.	2470441-00-8
Molecular Formula	C22H28ClN5O2
Molecular Weight	429.94 g/mol
Synonyms	2-{3-[4-(3-Chlorophenyl)-1-piperazinyl]propyl}-4-isobutoxy-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one hydrochloride; Trazodone Isobutyl Ether Related Compound Hcl; Trazodone Impurity Hcl (Isobutyl Ether); 1,2,4-Triazolo[4,3-a]pyridin-3(2H)-one, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-4-(2-methylpropoxy)-, hydrochloride; Trazodone EP Impurity H; Trazodone USP Related Compound H
EINECS	Contact for details

Quality Control

Every batch of Trazodone Isobutyl Ether Impurity Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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