Acalabrutinib Related Compounds & Impurities

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.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Acalabrutinib reference standards, pharmacopeial and non-pharmacopeial Acalabrutinib impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Acalabrutinib-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

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
Acalabrutinib Impurity 3

Metabolites

Acalabrutinib Metabolite 27

Isotope Labelled Compounds

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