Description

Dosulepin Impurity D is a high-purity chemical reference standard, specifically identified as a known impurity of the tricyclic antidepressant Dosulepin. This compound is critical for pharmaceutical research and development, enabling precise analytical method development and validation. It is primarily utilized by quality control laboratories, regulatory affairs departments, and R&D scientists in the pharmaceutical industry to ensure drug safety, efficacy, and compliance with stringent international pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Dosulepin Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine batch testing to ensure API and drug product purity meets specifications per ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Dosulepin.
• Pharmacopeial Testing: Used for testing against monographs in pharmacopeias such as USP, EP, or BP where control of this impurity is specified.

Basic Information

Product Name	Dosulepin Impurity D
CAS No.	25846-81-5
Molecular Formula	C19H21NS
Molecular Weight	295.44 g/mol
Synonyms	Dothiepin Impurity D; (E)-3-(Dibenzo[b,e]thiepin-11(6H)-ylidene)-N,N-dimethylpropan-1-amine; Prothiadene Impurity D; 11-(3-Dimethylaminoprop-1-enyl)-6,11-dihydrodibenzo[b,e]thiepine; Dosulepin Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Dosulepin Impurity D is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting requirements of pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters. We support compliance with ICH guidelines and can supply materials suitable for use in methods aligned with USP and EP standards.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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