Description

Bosutinib Impurity CAS NO 380843-12-9 is a specific chemical impurity associated with the active pharmaceutical ingredient (API) Bosutinib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Bosutinib drug substances and products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Bosutinib API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, LC-MS) in compliance with ICH Q2(R1) and other regulatory guidelines.
• Critical component in stability studies and forced degradation studies to understand the degradation pathways of Bosutinib.
• Used in pharmaceutical quality control (QC) laboratories for routine batch release testing and specification setting.
• Supports regulatory submissions (IND, NDA, ANDA) by providing necessary impurity profile data to agencies like the FDA and EMA.
• Valuable for academic and clinical research investigating the pharmacokinetics, metabolism, and safety profile of Bosutinib.

Basic Information

Product Name	Bosutinib Impurity
CAS No.	380843-12-9
Molecular Formula	C26H29Cl2N5O3
Molecular Weight	530.45 g/mol
Synonyms	Bosutinib Related Compound; Bosutinib Process Impurity; 4-[(2,4-Dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile; SKI-606 Impurity; Quinoline-3-carbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-; UNII-501Y8H6F5D component VNWKTOKETHGBQD-UHFFFAOYSA-N
EINECS	Contact for details

Quality Control

Every batch of Bosutinib Impurity (CAS 380843-12-9) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency in line with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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