Description

Ibrutinib Impurity 9 is a designated process-related impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Ibrutinib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of this specific impurity during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and production of targeted cancer therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ibrutinib Impurity 9 in API and finished drug products.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UPLC).
• Quality Control & Stability Studies: Used in routine batch release testing and long-term stability studies to monitor impurity levels and ensure product consistency over its shelf life.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during Ibrutinib synthesis, helping to optimize manufacturing processes to minimize its presence.

Basic Information

Product Name	Ibrutinib Impurity 9
CAS No.	2068022-09-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 9; Ibrutinib EP Impurity I; Ibrutinib USP Impurity; PCI-32765 Impurity 9; (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 9
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 9 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 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.