Description

Doxepin Related Compound C (25 Mg) ((E-3-(Dibenzo[B,E]Oxepin-11(6H)-Ylidene)-n-Methylpropan-1-Amine Hydrochloride) is a high-purity reference standard critical for analytical and quality control workflows in pharmaceutical development and manufacturing. This compound is essential for ensuring the identity, purity, and safety of the active pharmaceutical ingredient Doxepin by serving as a known impurity marker. It is primarily needed by research institutions, analytical laboratories, and pharmaceutical companies engaged in method validation, stability studies, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of specific impurities in Doxepin Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods to ensure specificity, accuracy, and precision for impurity detection.
• Stability-Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of related substances and establish shelf-life specifications.
• Regulatory Compliance and Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Quality Control Laboratory Testing: Acts as a system suitability standard and a calibrant in routine QC release testing of Doxepin batches to ensure they meet pharmacopeial standards (USP, EP).
• Research and Development: Utilized in synthetic chemistry research to study degradation pathways and to synthesize and characterize other related compounds.

Basic Information

Product Name	Doxepin Related Compound C (25 Mg) ((E-3-(Dibenzo[B,E]Oxepin-11(6H)-Ylidene)-n-Methylpropan-1-Amine Hydrochloride)
CAS No.	4504-96-5
Molecular Formula	C19H21NO·HCl
Molecular Weight	315.84 g/mol (Free base: 279.38 g/mol)
Synonyms	(E)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride; Doxepin Impurity C; Doxepin Related Substance C; Doxepin EP Impurity C; trans-3-(Dibenz[b,e]oxepin-11(6H)-ylidene)-N-methylpropylamine hydrochloride; NSC 108164; (E)-Doxepin Related Compound C
EINECS	Contact for details

Quality Control

Our Doxepin Related Compound C is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) detailing 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 light-sensitive; ensure the container is sealed immediately after use to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
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.