Description

Bosutinib Impurity 37 is a specified organic impurity associated with the active pharmaceutical ingredient Bosutinib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories involved in the production and regulatory compliance of Bosutinib.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bosutinib drug substance and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance: Employed in routine QC testing to ensure Bosutinib batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (light, heat, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Bosutinib Impurity 37
CAS No.	2095306-27-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bosutinib Related Compound 37; Bosutinib EP Impurity 37; Bosutinib USP Impurity 37; SKI-606 Impurity 37; (3-Quinolinecarbonitrile, 4-[(2,4-Dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-); 4-[(2,4-Dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile; An impurity of Bosutinib
EINECS	Contact for details

Quality Control

Our Bosutinib Impurity 37 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. We support our clients' regulatory needs with comprehensive documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

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 unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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