Description

Cyamemazine Impurity 3 is a specified impurity and a key reference standard used in the analytical profiling of the antipsychotic drug Cyamemazine. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments for method validation, stability studies, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cyamemazine Impurity 3 in drug substance and drug product analysis.
• Method Development and Validation (HPLC/LC-MS): Essential for developing and validating robust analytical methods to monitor impurity levels throughout the API synthesis and formulation process.
• Stability Indicating Method: Employed in forced degradation and long-term stability studies to track the formation of this specific degradation product.
• Quality Control and Batch Release: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with specifications.
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., ICH guidelines) to establish impurity thresholds and control strategies.
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Cyamemazine Impurity 3
CAS No.	1778-82-1
Molecular Formula	C19H21N3S
Molecular Weight	323.46 g/mol
Synonyms	10-[3-(Dimethylamino)-2-methylpropyl]-2-(methylthio)-10H-phenothiazine; 2-Methylthio-10-[3-(dimethylamino)-2-methylpropyl]phenothiazine; Desmethyl Cyamemazine; Norcyamemazine; Cyamemazine Desmethyl Impurity; Cyamemazine Related Compound C; CAS 1778-82-1
EINECS	Contact for details

Quality Control

Every batch of Cyamemazine Impurity 3 is manufactured and handled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, MS, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference material. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.