Description

Dasatinib Impurity 84 is a designated process-related impurity or degradation product of the active pharmaceutical ingredient Dasatinib, a tyrosine kinase inhibitor. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing to ensure product safety and regulatory compliance. It is an essential material for research and quality assurance laboratories in the pharmaceutical and biotechnology sectors, supporting activities from R&D to commercial production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dasatinib drug substance and finished dosage forms.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity acceptance criteria.
• Stability Studies: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Dasatinib Impurity 84
CAS No.	1044209-24-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dasatinib Related Compound 84; Dasatinib EP Impurity I; Dasatinib USP Related Compound; BMS-354825 Impurity 84; N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide Impurity; Sprycel Impurity 84; Dasatinib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Dasatinib Impurity 84 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), structural confirmation (NMR, MS), and related substance analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data, test methods, and results is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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