Acalabrutinib

Acalabrutinib is a second-generation, highly selective Bruton's tyrosine kinase (BTK) inhibitor used in chronic lymphocytic leukaemia and mantle cell lymphoma, designed to minimise off-target kinase inhibition seen with earlier BTK inhibitors. Its targeted mechanism and oncology indication call for stringent impurity control. Simson Pharma's Acalabrutinib reference standard and related impurities support stability-indicating assay development.

Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) supply high-quality Acalabrutinib Reference Standards, pharmacopoeial reference materials, and its related impurities to pharmaceutical manufacturers, CROs, analytical laboratories, universities, and regulatory organizations worldwide. To service the Europe and America market efficiently, Simson Pharma Limited has set up Simson Pharma Global Ltd. in United Kingdom and Simson Pharma Global LLC in USA respectively.

Pharmaceutical Reference Standards / Impurity Standards

Acalabrutinib
(5-Chloro pyrazin-2-yl) Methanamine
Acalabrutinib Impurity 5
3,5-Dichloro-2-pyrazinemethanamine
Acalabrutinib Impurity 7
Acalabrutinib Impurity 8
B-[2-[(2-Pyridinylamino)carbonyl]phenyl]boronic Acid
(3-(pyridin-2-ylcarbamoyl)phenyl)boronic acid
Acalabrutinib Impurity 11
Acalabrutinib -N-Oxide
(R)-2-(4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)benzamido)pyridine 1-oxide
Acalabrutinib Acetaldehyde
Acalabrutinib 8-Hydroxy Impurity
Acalabrutinib Nitroso Impurity 1
Acalabrutinib Impurity 25
Acalabrutinib R-Isomer
Acalabrutinib impurity 1
Acalabrutinib Impurity 20
Acalabrutinib Impurity 21
Acalabrutinib Impurity 22
Acalabrutinib Impurity 23 (S-isomer)
Acalabrutinib Impurity 24
Acalabrutinib Nitroso Impurity 2
Acalabrutinib Impurity 27
Acalabrutinib Impurity 30
Acalabrutinib Impurity 31
Acalabrutinib Impurity 28
Acalabrutinib Impurity 32
Acalabrutinib Impurity 23
Acalabrutinib Impurity 2
Acalabrutinib Maleate Monohydrate
Acalabrutinib Impurity 36
Acalabrutinib Impurity 33
Acalabrutinib Impurity 17
Acalabrutinib Acetyl Impurity
Acalabrutinib Impurity 34
Acalabrutinib Impurity 9
Acalabrutinib Impurity 10
Acalabrutinib Impurity 41
Acalabrutinib Impurity 42
Acalabrutinib Impurity 6
Acalabrutinib Impurity 12
Acalabrutinib Impurity 13
Acalabrutinib Impurity 14
Acalabrutinib Impurity 15
Acalabrutinib Impurity 18
Acalabrutinib Impurity 19
Acalabrutinib Impurity 26
Acalabrutinib Impurity 16
Acalabrutinib Benzyl Impurity
Acalabrutinib Impurity 29
Acalabrutinib-N-Formyl
N-Nitroso Acalabrutinib Impurity 1

Metabolites

Acalabrutinib Metabolite 27

Isotope Labelled Compounds

Acalabrutinib-D4
Acalabrutinib Metabolite-D4
Acalabrutinib Metabolite-D4
Calquence D4