Abemaciclib Related Compounds & Impurities

Abemaciclib is an oral CDK4/6 inhibitor that arrests the cell cycle at the G1-to-S transition in hormone receptor-positive breast cancer cells, typically used in combination with endocrine therapy.

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 Abemaciclib reference standards, pharmacopeial and non-pharmacopeial Abemaciclib 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 Abemaciclib-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

Abemaciclib
Abemaciclib mesylate
Abemaciclib Desfluoro Pyrimidine Imidazole Impurity
Abemaciclib Nitroso Metabolites M2
Abemaciclib Nitroso Impurity 2
Abemaciclib Nitroso Impurity 3
Abemaciclib Nitroso Impurity 1
Abemaciclib Impurity 11
Abemaciclib Impurity 12
Abemaciclib Impurity 13
Abemaciclib Impurity 14
Abemaciclib Impurity 15
Abemaciclib Nitroso Impurity 4
Abemaciclib Impurity 22
Abemaciclib Impurity 7
Abemaciclib Impurity 6
Abemaciclib Impurity 24
Abemaciclib Impurity 18
Abemaciclib Impurity 17
Abemaciclib Impurity 16
Abemaciclib Impurity 28
Abemaciclib Impurity 29
Abemaciclib Impurity 21
Abemaciclib Impurity 30
Abemaciclib Impurity 31
Abemaciclib Impurity 32
6-Chloro-5-fluoropyrimidin-2(1H)-one
5-(Piperazin-1-ylmethyl)pyridin-2-amine
Abemaciclib Nitroso Impurity 5
Abemaciclib nitroso impurity 6
Abemaciclib Impurity 4
Abemaciclib nitroso impurity 7
Abemaciclib nitroso impurity 8
Abemaciclib nitroso impurity 9
Abemaciclib nitroso impurity 10
Abemaciclib Impurity 33
Abemaciclib Impurity 34
Abemaciclib Impurity 35
Abemaciclib Impurity 36
Abemaciclib Impurity 5
Abemaciclib N-Oxide Impurity 1
Abemaciclib Impurity 37
Abemaciclib Impurity 38
Abemaciclib Impurity 39
Abemaciclib Impurity 40
Abemaciclib Impurity 8
Abemaciclib Impurity 9
Abemaciclib Impurity 10
Abemaciclib N-Oxide Impurity 2
Abemaciclib Impurity 19
Abemaciclib Impurity 20
N-Nitroso Abemaciclib Impurity 1
N-Nitroso Abemaciclib Impurity 2
Abemaciclib Impurity 23
Abemaciclib Alcohol Dimer Impurity
Abemaciclib Desethyl Dimer Impurity
Abemaciclib Des-Ethyl Nitroso Impurity
N-Nitroso Abemaciclib Impurity 3
Abemaciclib Impurity 25
Abemaciclib Impurity 26
Abemaciclib impurity 27
Abemaciclib Impurity 42
Abemaciclib Impurity 41
Abemaciclib Nitroso Impurity 11
Abemaciclib Alcohol Dimer Impurity 1

Metabolites

Abemaciclib Metabolites M2
Abemaciclib Metabolite M20
Abemaciclib Metabolite M18

Isotope Labelled Compounds

Abemaciclib D8
Abemaciclib D5