Description

Dasatinib Impurity CAS NO 1935225-16-3 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Dasatinib, a targeted cancer therapy. It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure drug substance purity and to meet stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Dasatinib active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing within pharmaceutical QC laboratories to ensure API and drug product specifications are met.
• Regulatory Compliance and Submissions: Essential for generating data required for regulatory filings (e.g., with the FDA, EMA) to demonstrate thorough impurity characterization and control.
• Stability Studies: Used as a marker to monitor the formation of degradation products in Dasatinib formulations under various stress conditions.
• Research and Development: Supports synthetic chemistry research by providing a characterized sample for studying the degradation pathways and metabolism of Dasatinib.

Basic Information

Product Name	Dasatinib Impurity
CAS No.	1935225-16-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dasatinib Related Compound; Dasatinib Process Impurity; Dasatinib Degradant; BMS-354825 Impurity; N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide derivative; Sprycel Impurity; Tyrosine kinase inhibitor impurity
EINECS	Contact for details

Quality Control

Every batch of Dasatinib Impurity CAS NO 1935225-16-3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request, supporting compliance with ICH Q3A/B guidelines and current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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)	≤ 5.0%

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