Description

Dasatinib Impurity 35 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Dasatinib during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories for method development, validation, and regulatory compliance. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Dasatinib API.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels in accordance with ICH Q3A/B guidelines.
• Regulatory Compliance & Filings: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization.
• Stability Studies: Used to identify and quantify degradation products formed under various stress conditions.
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of Dasatinib during process development.

Basic Information

Product Name	Dasatinib Impurity 35
CAS No.	1025814-13-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dasatinib Related Compound 35; Dasatinib EP Impurity 35; Dasatinib USP Impurity 35; Dasatinib Process Impurity; BMS-354825 Impurity 35; N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide Impurity; Sprycel Impurity 35
EINECS	Contact for details

Quality Control

Our Dasatinib Impurity 35 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assay and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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.

Specification

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

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