Description

Abemaciclib CAS NO 1650550-25-6 is a potent and selective small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). This compound is of significant commercial and therapeutic importance as a key active pharmaceutical ingredient (API) in targeted cancer therapies. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in oncology drug development and production.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of commercial anti-cancer drugs, specifically for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
• Oncology Research: Critical tool compound for in vitro and in vivo studies investigating CDK4/6 inhibition, cell cycle progression, and mechanisms of drug resistance.
• Drug Discovery & Development: Used as a reference standard and building block in the discovery and optimization of next-generation CDK inhibitors and combination therapies.
• GMP Manufacturing: Sourced by contract manufacturing organizations (CMOs) and finished dosage formulators for the production of commercial tablets under current Good Manufacturing Practice (cGMP) standards.
• Analytical Reference: Serves as a high-purity standard for quality control (QC) and analytical method development (e.g., HPLC, LC-MS) in pharmaceutical laboratories.

Basic Information

Product Name	Abemaciclib
CAS No.	1650550-25-6
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-1-(propan-2-yl)benzimidazol-6-yl]pyrimidin-2-amine; Abemaciclibum; CDK4/6 Inhibitor LY2835219; Abemaciclib (USAN); Abemaciclib free base
EINECS	Contact for details

Quality Control

Our Abemaciclib is manufactured and tested to meet the stringent requirements of pharmaceutical-grade active ingredients. Quality is assured through a comprehensive battery of analytical tests including identification, assay, impurity profiling (related substances), residual solvents, and heavy metals. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with in-house specifications aligned with ICH guidelines. Material can be supplied under a Quality Agreement to support regulatory filings (e.g., DMF, CMC sections).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under an 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 ≤1.5% Any single unknown impurity ≤0.10%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤20 ppm
Loss on Drying	≤0.5%

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