Description

R-Acalabrutinib CAS NO 1952316-43-6 is a high-purity, enantiomerically pure pharmaceutical intermediate and reference standard. This compound is a critical chiral building block in the synthesis of Acalabrutinib, a potent and selective second-generation Bruton's tyrosine kinase (BTK) inhibitor. It is essential for pharmaceutical R&D, process development, and quality control laboratories requiring a definitive standard for stereochemical purity. Target industries include pharmaceutical manufacturing, contract research organizations (CROs), and academic institutions focused on oncology drug development.

Application

• Primary reference standard for the analytical method development and validation of Acalabrutinib API.
• Critical chiral intermediate in the research-scale and commercial synthesis of Acalabrutinib.
• Used in pharmacokinetic and metabolic stability studies for impurity profiling and identification.
• Essential material for regulatory filings (e.g., IND, NDA) to demonstrate control over stereochemistry.
• Key starting material (KSM) or advanced intermediate in process chemistry optimization.
• Biochemical research tool for studying BTK inhibition mechanisms and structure-activity relationships (SAR).

Basic Information

Product Name	R-Acalabrutinib
CAS No.	1952316-43-6
Molecular Formula	C26H23N7O2
Molecular Weight	465.51 g/mol
Synonyms	(R)-Acalabrutinib; (R)-ACP-196; (R)-4-{8-Amino-3-[(2S)-1-(but-2-ynoyl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl}-N-(2-pyridinyl)benzamide; ACP-196 Impurity R; R-Enantiomer of Acalabrutinib; UNII-1K8L4WQ8VJ (enantiomer); BTK Inhibitor (R)-Enantiomer; (R)-BGB-3111 (related compound)
EINECS	Contact for details

Quality Control

Our R-Acalabrutinib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral HPLC for enantiomeric excess (typically >99.0%), identity confirmation by IR and MS, and rigorous control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with cGMP guidelines for advanced pharmaceutical intermediates.

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 a dry atmosphere to prevent degradation. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Single Maximum Impurity	≤ 0.5%
Total Impurities	≤ 1.5%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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