Description

Ibrutinib Impurity 14 is a designated impurity of the active pharmaceutical ingredient (API) Ibrutinib, a critical tyrosine kinase inhibitor used in targeted cancer therapies. This compound is essential for pharmaceutical research and development, serving as a key reference standard for method development, validation, and quality control to ensure the purity and safety of the final drug product. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ibrutinib Impurity 14 in drug substance and drug product batches.
• Analytical Method Development: Critical for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) for impurity profiling of Ibrutinib.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and scale-up of Ibrutinib API.

Basic Information

Product Name	Ibrutinib Impurity 14
CAS No.	2417548-76-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibrutinib Related Compound 14; Ibrutinib EP Impurity 14; Ibrutinib USP Impurity 14; Ibrutinib Process Impurity 14; (S)-1-((R)-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 14; PCI-32765 Impurity 14
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry 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 and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. For long-term storage, consider storing desiccated at -20°C. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches 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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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