Description

Bosutinib Impurity 7 is a specified organic compound used as a reference standard in pharmaceutical research and development. This impurity is critical for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Bosutinib, a kinase inhibitor medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and efficacy. The compound is essential for method validation, stability studies, and meeting stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bosutinib API batches.
• 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 QC testing to monitor impurity levels and ensure batch-to-batch consistency of the final drug product.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require complete impurity identification and qualification data.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish drug shelf life.
• Research & Development: Utilized in process chemistry R&D to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Bosutinib Impurity 7
CAS No.	219786-51-3
Molecular Formula	C26H29Cl2N5O3
Molecular Weight	530.45 g/mol
Synonyms	Bosutinib Related Compound 7; 4-[(2,4-Dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile; UNII-9V3F8J31QN; SKI-606 Impurity 7; Bosutinib EP Impurity C; Bosutinib Impurity C (EP); Bosutinib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Bosutinib Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials qualified against USP or EP reference standards upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or storage under an inert atmosphere to maintain stability and purity.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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