Description

Dasatinib Impurity 15 is a designated impurity associated with the active pharmaceutical ingredient Dasatinib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, specifically for method development, stability studies, and ensuring the quality and safety of the final drug product. It is an essential reference standard for analytical laboratories and manufacturers involved in the production and quality control of Dasatinib.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Dasatinib and its related substances.
• Analytical Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Stability and Forced Degradation Studies: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release: Serves as a system suitability standard and for setting impurity acceptance criteria in the quality control testing of Dasatinib drug substance and drug product.
• Regulatory Compliance and Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research and Development: Used in R&D to study the degradation pathways and chemical behavior of Dasatinib, aiding in process optimization and formulation development.

Basic Information

Product Name	Dasatinib Impurity 15
CAS No.	2468737-80-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dasatinib Related Compound 15; Dasatinib EP Impurity J; Dasatinib USP Impurity; Dasatinib Process Impurity; BMS-354825 Impurity 15; N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Dasatinib Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling. Certificates of Analysis (COA) containing detailed analytical results from techniques such as HPLC, NMR, and MS are available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material 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 (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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