Description

Abemaciclib is a potent and selective small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which are key regulators of the cell cycle. This targeted therapeutic agent is crucial for disrupting the uncontrolled proliferation of cancer cells, offering a mechanism-based approach to oncology treatment. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of innovative cancer therapies, particularly for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in finished dosage forms for the treatment of specific breast cancers.
• Oncology Drug Development: Critical raw material for R&D and manufacturing of CDK4/6 inhibitor class drugs.
• Clinical Research: Used in the formulation of investigational medicinal products for clinical trials exploring new indications or combination therapies.
• Reference Standard: Serves as a high-purity chemical reference standard for analytical method development, validation, and quality control testing.
• Biochemical Research: Tool compound for in vitro and in vivo studies to investigate cell cycle dynamics, drug resistance mechanisms, and cancer biology.

Basic Information

Product Name	Abemaciclib
CAS No.	1231929-97-7
Molecular Formula	C27H32F2N8
Molecular Weight	506.60 g/mol
Synonyms	LY2835219; Verzenio (Trade Name); N-[5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl]-5-fluoro-4-[4-fluoro-2-methyl-1H-indol-5-yl]oxy]pyrrolo[2,3-d]pyrimidin-7-amine; Abemaciclib free base; CDK4/6 Inhibitor LY2835219
EINECS	Contact for details

Quality Control

Our Abemaciclib is manufactured under strict quality management systems to meet the exacting standards of the pharmaceutical industry. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling via advanced techniques like HPLC and mass spectrometry. A Certificate of Analysis (COA) detailing all test results against relevant specifications is provided with every shipment to ensure full traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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