Description

Ibrutinib Impurity 4 is a specified impurity associated with the active pharmaceutical ingredient Ibrutinib, a Bruton's tyrosine kinase (BTK) 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 essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Ibrutinib-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ibrutinib drug substance and finished products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and analyze Ibrutinib and its related substances.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure compliance with strict pharmacopeial (USP, EP, ICH) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf-life.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Ibrutinib.

Basic Information

Product Name	Ibrutinib Impurity 4
CAS No.	1807619-68-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 4; Ibrutinib Impurity D; Ibrutinib EP Impurity D; Ibrutinib USP Impurity; BTK Inhibitor Impurity; (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
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry and pharmacopeial standards. 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 in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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