General Information

Acalabrutinib Impurities and Acalabrutinib  

Daicel Pharma synthesizes high-quality Acalabrutinib impurities, ACA-Benzoic acid impurity, ACA-dibutynoyl impurity, ACA-N-oxide impurity 2, Acalabrutinib dimer impurity, Acalabrutinib R-isomer, and more, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Acalabrutinib. Moreover, Daicel Pharma offers custom synthesis of Acalabrutinib impurities and delivers them globally.

Acalabrutinib [CAS:1420477-60-6] is a potential antineoplastic oral medicine. It functions by blocking the activity of Bruton’s tyrosine kinase (BTK), a protein that plays a role in the formation of B cell malignancies.

Acalabrutinib: Use and Commercial Availability  

Acalabrutinib, under the trade name CALQUENCE, is a medicine for treating Mantle Cell Lymphoma (MCL) in adult patients who have already undergone at least one prior therapy. More recently, it is for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma.

Acalabrutinib Structure and Mechanism of Action

The chemical name of Acalabrutinib is 4-[8-Amino-3-[(2S)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl]-N-2-pyridinylbenzamide. Its chemical formula is C₂₆H₂₃N₇O_2, and its molecular weight is approximately 465.5 g/mol.

Acalabrutinib is a small-molecule BTK inhibitor. It forms a covalent bond with a cysteine residue in the BTK active site, inhibiting BTK enzymatic activity.

Acalabrutinib Impurities and Synthesis

During the manufacturing¹ of Acalabrutinib, impurities may form as by-products. These impurities are from the starting materials, intermediates, or reaction by-products. The common Acalabrutinib impurities include related substances, degradants, and residual solvents. Some of these impurities may affect the safety and efficacy of the drug product, and thus their levels must be controlled and monitored within acceptable limits.

Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Acalabrutinib impurities, ACA-Benzoic acid impurity, ACA-dibutynoyl impurity, ACA-N-oxide impurity 2, Acalabrutinib dimer impurity, Acalabrutinib R-isomer, and more. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We also provide 13C-DEPT and CHN on request. We give a complete characterization report on delivery. Daicel has the technology and expertise to prepare any unknown Acalabrutinib impurity or degradation product. We also provide labeled compounds to quantify the efficacy of Acalabrutinib. Daicel offers Acalabrutinib-D4, a deuterium-labeled Acalabrutinib standard, used in bio-analytical research such as BA/BE studies with isotope data in CoA.