Description

Dasatinib Impurity CAS NO 1184919-23-0 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dasatinib. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments involved in the development and production of Dasatinib-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Dasatinib API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Aids in understanding the degradation pathways and chemical behavior of Dasatinib during process development.

Basic Information

Product Name	Dasatinib Impurity
CAS No.	1184919-23-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dasatinib Related Compound; Dasatinib Impurity Standard; Dasatinib Specified Impurity; BMS-354825 Impurity; N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide Impurity; Sprycel Impurity; Dasatinib Degradation Product; Dasatinib Process Impurity
EINECS	Contact for details

Quality Control

Our Dasatinib Impurity is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch undergoes rigorous testing, including identification by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC). A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, purity, and impurity content, ensuring full traceability and compliance with cGMP principles and 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 desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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