Description

Bosutinib Impurity 5 is a designated impurity of the tyrosine kinase inhibitor Bosutinib, identified by the CAS registry number 2095306-22-0. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and biotechnology sectors to ensure drug purity, safety, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bosutinib API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Bosutinib meets pharmacopeial (USP, EP) and internal specification limits for impurities.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of the drug substance and product.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify control strategies.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during Bosutinib synthesis, helping to optimize manufacturing processes to minimize its generation.

Basic Information

Product Name	Bosutinib Impurity 5
CAS No.	2095306-22-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bosutinib Related Compound 5; Bosutinib Impurity; 4-[(2,4-Dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile Impurity; SKI-606 Impurity 5; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Bosutinib Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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