Description

Dosulepin Impurity A is a specified impurity of the tricyclic antidepressant drug Dosulepin (also known as Dothiepin). This compound is a critical reference standard used in pharmaceutical research and development to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient. It is essential for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. This impurity is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies involved in the production and testing of Dosulepin.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dosulepin API and finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or GC methods to separate and detect impurities in drug substances.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation of degradation products under various stress conditions as part of drug stability testing programs.
• Pharmacopoeial Testing: Applicable for testing against monographs in pharmacopoeias such as USP, EP, or BP where control of related substances is specified.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and process impurity profiling.

Basic Information

Product Name	Dosulepin Impurity A
CAS No.	42046-35-5
Molecular Formula	C19H21NS
Molecular Weight	295.44 g/mol
Synonyms	Dothiepin Impurity A; 3-(10,11-Dihydro-5H-dibenzo[b,f]thiepin-5-ylidene)-N,N-dimethyl-1-propanamine; Dothiepin EP Impurity A; Dothiepin Related Compound A; Prothiadene Impurity A; (E)-3-(Dibenzo[b,f]thiepin-10(11H)-ylidene)-N,N-dimethylpropan-1-amine; 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[b,f]thiepin-5-ylidene)-N,N-dimethyl-
EINECS	Contact for details

Quality Control

Our Dosulepin Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, to ensure it meets the high standards required for pharmaceutical reference materials. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results for identity, purity, and impurities. The material is suitable for use in methods validated per ICH guidelines.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.