Description

Ibrutinib Dimer Impurity is a high-purity reference standard critical for analytical method development and validation in pharmaceutical research and manufacturing. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Ibrutinib by accurately identifying and quantifying its dimeric impurity. It is primarily used by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in the development and production of targeted cancer therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Ibrutinib and related drug substances.
• Method Development and Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles in Ibrutinib API and finished dosage forms.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with stringent ICH Q3A/B guidelines on impurities.
• Stability Studies: Serves as a key marker in forced degradation and long-term stability studies to understand the degradation pathways of Ibrutinib.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Process Chemistry Research: Used by chemists to optimize synthesis and purification processes to minimize the formation of this specific dimer impurity.

Basic Information

Product Name	Ibrutinib Dimer Impurity
CAS No.	2031255-23-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Dimer; Ibrutinib Related Compound Dimer; Ibrutinib Impurity Dimer; PCI-32765 Dimer Impurity; (S)-1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)-4-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)but-2-en-1-one (proposed); BTK Inhibitor Dimer Impurity
EINECS	Contact for details

Quality Control

Our Ibrutinib Dimer Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, mass spectrometry (MS) for structural confirmation, and NMR spectroscopy, to ensure identity, potency, and purity. Certificates of Analysis (COA) containing detailed chromatographic data and results are provided and traceable to primary reference standards. Our quality commitment aligns with ICH guidelines and supports cGMP-compliant pharmaceutical development.

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 under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.