Description

Ibrutinib Impurity 6 is a specified impurity associated with the active pharmaceutical ingredient (API) Ibrutinib, a critical tyrosine kinase inhibitor. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the production and regulatory compliance of Ibrutinib-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ibrutinib API and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to track the formation and levels of this impurity during forced degradation and long-term stability studies of Ibrutinib.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Ibrutinib to minimize impurity formation.

Basic Information

Product Name	Ibrutinib Impurity 6
CAS No.	1917333-91-5
Molecular Formula	C25H24N6O2
Molecular Weight	440.50 g/mol
Synonyms	Ibrutinib Related Compound 6; Ibrutinib Impurity C; (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; UNII-9J2S5L8R3F; 1H-Pyrazolo[3,4-d]pyrimidine, 4-amino-3-(4-phenoxyphenyl)-1-[(3R)-1-[(1R)-2-oxo-1-propen-1-yl]-3-piperidinyl]-; Ibrutinib EP Impurity C; Ibrutinib USP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with ICH guidelines and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.