Description

Acalabrutinib CAS NO 1420477-60-6 is a potent, selective, and irreversible second-generation Bruton's tyrosine kinase (BTK) inhibitor. It is a critical active pharmaceutical ingredient (API) used in the development and manufacture of targeted cancer therapies. This compound is primarily utilized by pharmaceutical companies and research institutions focused on oncology, particularly for the treatment of B-cell malignancies such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms for targeted cancer therapy.
• Oncology Drug Development: Key component in preclinical and clinical research for novel BTK-inhibitor-based treatments.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.
• Biochemical Research: Used as a selective tool compound to study BTK signaling pathways and their role in immune cell function and disease.
• Formulation Development: Employed in the development of various drug delivery systems, including tablets and capsules.
• Process Chemistry: Used in scaling up and optimizing synthetic routes for commercial manufacturing.

Basic Information

Product Name	Acalabrutinib
CAS No.	1420477-60-6
Molecular Formula	C26H23N7O2
Molecular Weight	465.51 g/mol
Synonyms	ACP-196; Acalabrutinib (ACP-196); (S)-4-(8-Amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide; Calquence (Brand Name); ACP 196; UNII-1X70OSD4V; BDBM50377779.
EINECS	Contact for details

Quality Control

Our Acalabrutinib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength, meeting specifications suitable for pharmaceutical research and development. We provide full traceability and Certificates of Analysis (COA) are available for all shipments, detailing results from tests including HPLC assay, chiral purity, and related substances analysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Chiral Purity (HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤0.5%
Heavy Metals	≤20 ppm

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