Description

Ibrutinib Impurity 15 is a designated impurity 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 process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory compliance teams involved in the development and manufacturing of targeted cancer therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ibrutinib Impurity 15 in API and finished drug products.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Ibrutinib API meets stringent pharmacopeial (e.g., USP, EP) and internal specification limits for impurities.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions and throughout the drug's shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Ibrutinib to minimize the formation of this impurity.

Basic Information

Product Name	Ibrutinib Impurity 15
CAS No.	1288338-97-5
Molecular Formula	C25H24N6O2
Molecular Weight	440.50 g/mol
Synonyms	PCI-32765 Impurity 15; Ibrutinib Related Compound 15; (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; Ibrutinib EP Impurity C; Ibrutinib USP Impurity; BTK Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 15 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment to maintain stability and purity.

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 unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.