Description

Bosutinib Impurity 5 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Bosutinib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of tyrosine kinase inhibitor medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Bosutinib API and finished dosage forms.
• Method Development & Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UHPLC).
• Quality Control (QC) & Quality Assurance (QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products in Bosutinib under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during the synthesis of Bosutinib.

Basic Information

Product Name	Bosutinib Impurity 5
CAS No.	1391063-17-4
Molecular Formula	C26H29Cl2N5O3
Molecular Weight	530.45 g/mol
Synonyms	Bosutinib Related Compound 5; Bosutinib Impurity; 4-[(2,4-Dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile; SKI-606 Impurity 5; 1,3-Benzenediamine, N4-(2,4-dichloro-5-methoxyphenyl)-6-methoxy-N7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile; UNII-0Q3Q6N3K8P
EINECS	Contact for details

Quality Control

Our Bosutinib Impurity 5 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, HPLC), assay (HPLC), and related substance analysis. We adhere to high-purity standards suitable for pharmaceutical reference material applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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