Description

Ibrutinib Impurity 24 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, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Ibrutinib-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ibrutinib Impurity 24 in drug substances and finished products.
• Analytical Method Development: Critical for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to track the formation and levels of this impurity under various stress conditions to determine drug product shelf-life.
• Process Chemistry Research: Aids in understanding and optimizing the Ibrutinib synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Ibrutinib Impurity 24
CAS No.	2244619-11-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 24; Ibrutinib EP Impurity I; Ibrutinib USP Impurity; PCI-32765 Impurity 24; (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 24
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques like HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.