Description

Bosutinib Impurity 2 (n-Desmethyl Bosutinib) is a key pharmaceutical reference standard and impurity used in the research, development, and quality control of the oncology drug Bosutinib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in API synthesis, method validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of impurities in Bosutinib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, LC-MS, and other chromatographic methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Process Chemistry Research: Used to study and optimize the Bosutinib synthesis pathway, helping to understand and minimize the formation of this specific impurity.
• Regulatory Documentation: Supports the preparation of regulatory filings (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed as a marker to assess the degradation profile of Bosutinib under various storage conditions over time.

Basic Information

Product Name	Bosutinib Impurity 2 (n-Desmethyl Bosutinib)
CAS No.	380843-81-2
Molecular Formula	C26H29Cl2N5O3
Molecular Weight	530.45 g/mol
Synonyms	n-Desmethyl Bosutinib; Desmethyl Bosutinib; Bosutinib Desmethyl Impurity; Bosutinib N-Desmethyl; 4-[(2,4-Dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile; SKI-606 Impurity 2; BOS-Imp-02
EINECS	Contact for details

Quality Control

Every batch of Bosutinib Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic characterization (NMR, MS), to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
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.