Description

Bosutinib Impurity 38 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Bosutinib, a tyrosine kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for meeting stringent regulatory compliance in drug development and production.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Bosutinib API.
• Method Development and Validation in analytical laboratories for HPLC, LC-MS, and other chromatographic techniques.
• Quality Control (QC) and Quality Assurance (QA) in pharmaceutical manufacturing to ensure batch-to-batch consistency.
• Stability Studies to monitor impurity profiles in drug substances and products over time.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Research and Development for studying the degradation pathways and metabolism of Bosutinib.

Basic Information

Product Name	Bosutinib Impurity 38
CAS No.	2095306-26-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bosutinib Related Compound 38; Bosutinib Impurity; 2095306-26-4; UNII-9Q2F9I8W4K; (3-Quinolinylmethyl)-carbamic acid (1R)-1-phenylethyl ester; 1-[(1R)-1-Phenylethyl] 3-(quinolin-3-ylmethyl) carbamate
EINECS	Contact for details

Quality Control

Our Bosutinib Impurity 38 is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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