Description

Ibrutinib is a potent, selective, and irreversible small-molecule inhibitor of Bruton's tyrosine kinase (BTK), a critical enzyme in the B-cell receptor signaling pathway. This targeted mechanism of action makes it a cornerstone therapeutic agent in the treatment of various B-cell malignancies. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in oncology drug development. The compound, supplied as Ibrutinib CAS NO 936563-96-1, is essential for the formulation of finished dosage forms and advanced clinical research.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the commercial manufacturing of finished drug products for the treatment of B-cell cancers.
• Oncology Research: Critical reagent in preclinical and clinical studies investigating B-cell signaling pathways and hematologic malignancies.
• Pharmaceutical Development: Used in formulation studies for solid oral dosage forms such as tablets and capsules.
• Reference Standard: Serves as a high-purity chemical standard for analytical method development and quality control testing.
• Combinatorial Therapy Research: Investigated in combination with other anticancer agents to enhance therapeutic efficacy.
• Mechanistic Studies: Tool compound for biochemical and cellular assays to elucidate BTK inhibition and its downstream effects.

Basic Information

Product Name	Ibrutinib
CAS No.	936563-96-1
Molecular Formula	C₂₅H₂₄N₆O₂
Molecular Weight	440.50 g/mol
Synonyms	PCI-32765; Imbruvica (trade name); 1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one; BTK Inhibitor PCI-32765; Bruton's Tyrosine Kinase Inhibitor PCI-32765
EINECS	Contact for details

Quality Control

Our Ibrutinib is manufactured under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identification, purity assay, and impurity profiling via advanced techniques like HPLC and LC-MS. A Certificate of Analysis (COA) documenting full compliance with agreed specifications is provided with every shipment. We support development with grades suitable for research through to cGMP-compliant material for commercial drug substance manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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