Description

Ibrutinib Impurity 42 is a specified impurity of the active pharmaceutical ingredient (API) Ibrutinib, a critical tyrosine kinase inhibitor. This compound is essential for pharmaceutical research and development, particularly in the analytical method development and validation required for drug substance quality control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and contract research organizations (CROs) to ensure the purity, safety, and regulatory compliance of Ibrutinib-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ibrutinib Impurity 42 in drug substance and finished product testing.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles in Ibrutinib API.
• Quality Control & Batch Release: Used as a system suitability standard in quality control laboratories to ensure the accuracy and precision of impurity assays for commercial batch release.
• Stability Studies: Employed to track the formation and levels of this specific degradation product during forced degradation and long-term stability studies of Ibrutinib.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to establish impurity acceptance criteria as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Process Chemistry Research: Aids in the optimization of Ibrutinib synthesis and purification processes by identifying and controlling the source of this impurity.

Basic Information

Product Name	Ibrutinib Impurity 42
CAS No.	2031255-24-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 42; Ibrutinib Specified Impurity 42; PCI-32765 Impurity 42; (R)-1-((3R)-3-(4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one Impurity; BTK Inhibitor Impurity 42
EINECS	Contact for details

Quality Control

Our Ibrutinib Impurity 42 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every 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 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 reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.