Description

(E)-n-Desmethyl-n-Formyl Doxepin CAS NO 250331-52-3 is a high-purity pharmaceutical intermediate and reference standard of significant importance in analytical chemistry and drug development. This compound is critical for ensuring the quality, safety, and efficacy of related active pharmaceutical ingredients (APIs) and finished drug products. It is primarily needed by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in the synthesis, impurity profiling, and quality control of tricyclic antidepressant compounds and their metabolites.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of doxepin and its related substances in compliance with pharmacopeial methods (e.g., USP, EP).
• Impurity Profiling and Control: Serves as a key impurity standard in the development and validation of analytical methods for monitoring process-related impurities and degradation products in active pharmaceutical ingredients (APIs).
• Metabolite Studies: Employed in pharmacokinetic and pharmacodynamic research as a metabolite reference compound for in-vitro and in-vivo studies.
• Method Development & Validation: Essential for HPLC, LC-MS, and GC-MS method development, ensuring accurate identification and quantification in complex matrices.
• Quality Assurance/Quality Control (QA/QC): Integral for the routine batch release testing of pharmaceutical raw materials and finished products to meet stringent regulatory requirements.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity limits and specifications.

Basic Information

Product Name	(E)-n-Desmethyl-n-Formyl Doxepin
CAS No.	250331-52-3
Molecular Formula	C18H19NO2
Molecular Weight	281.35 g/mol
Synonyms	(E)-N-Desmethyl-N-formyldoxepin; (E)-1-Desmethyl-1-formyldoxepin; (E)-Doxepin N-Desmethyl-N-Formyl Impurity; Doxepin Impurity F (E-isomer); (11E)-11-(3-Dimethylaminopropylidene)-6,11-dihydrodibenz[b,e]oxepin-2-carbaldehyde; 250331-52-3; Doxepin Related Compound F
EINECS	Contact for details

Quality Control

Our (E)-n-Desmethyl-n-Formyl Doxepin is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are available upon request.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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