Description

Dasatinib Dimeric Impurity is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dasatinib. This compound is essential for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control this specific impurity during drug development and production, ensuring final product safety and regulatory compliance. It is primarily used by researchers and quality control professionals in the pharmaceutical and biotechnology industries for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of the dimeric impurity in Dasatinib API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: Critical for establishing specification limits and testing commercial batches of Dasatinib to meet pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation and growth of this impurity in Dasatinib under various stress and long-term storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Dasatinib Dimeric Impurity
CAS No.	910297-61-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dasatinib Dimer; Dasatinib Related Compound Dimer; BMS-354825 Dimeric Impurity; N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide Dimer; Dasatinib Impurity Dimer
EINECS	Contact for details

Quality Control

Our Dasatinib Dimeric Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every 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 prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total Impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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