Description

Ibrutinib Impurity 3 is a specified impurity of the active pharmaceutical ingredient Ibrutinib, a targeted therapy used in oncology. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control of Ibrutinib drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Ibrutinib.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to detect and quantify this specific impurity.
• Quality Control & Assurance: Employed in routine QC testing of Ibrutinib active pharmaceutical ingredient (API) and finished drug products to monitor impurity profiles.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity identification and characterization data.
• Stability Studies: Used to track the formation and level of this impurity under various stress conditions and throughout product shelf-life.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Ibrutinib to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Ibrutinib Impurity 3
CAS No.	1226872-27-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 3; Ibrutinib EP Impurity C; Ibrutinib USP Impurity; PCI-32765 Impurity 3; (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 (enantiomer related to Ibrutinib); Ibrutinib Enantiomer; Ibrutinib Impurity C (EP); BTK Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). 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 in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under an inert atmosphere or in a desiccator to prevent degradation.

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%
Water Content (KF)	≤ 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.