Description

(Z)-Desmethyldoxepin CAS NO 58534-46-6 is a high-purity pharmaceutical intermediate and reference standard of significant importance in modern drug development and quality control. This compound is a key metabolite and synthetic precursor in the production and analysis of tricyclic antidepressant agents, most notably doxepin. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in active pharmaceutical ingredient (API) synthesis, pharmacokinetic studies, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of the tricyclic antidepressant drug, Doxepin.
• Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of desmethyldoxepin in drug substance and finished product analysis.
• Metabolite Studies: Essential for in-vitro and in-vivo pharmacokinetic and metabolism studies of doxepin.
• Impurity Profiling: Serves as a specified impurity standard to monitor and control quality during API manufacturing according to ICH guidelines.
• Analytical Research: Utilized in method development and validation for HPLC, LC-MS, and other chromatographic techniques in regulatory testing.
• Biochemical Research: Employed in neuroscience and pharmacology research to study the mechanism of action of tricyclic compounds.

Basic Information

Product Name	(Z)-Desmethyldoxepin
CAS No.	58534-46-6
Molecular Formula	C18H19NO
Molecular Weight	265.35 g/mol
Synonyms	(Z)-Desmethyldoxepin; (Z)-N-Desmethyldoxepin; (Z)-Nordoxepin; (11Z)-11-(3-Dimethylaminopropylidene)-6,11-dihydrodibenz[b,e]oxepin; (Z)-Doxepin Metabolite; Desmethyldoxepin (Z-isomer); cis-Desmethyldoxepin
EINECS	Contact for details

Quality Control

Our (Z)-Desmethyldoxepin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with cGMP and ICH Q3 guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The compound is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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