Description

Abemaciclib D8 CAS NO 2088650-53-5 is a deuterated analog of the active pharmaceutical ingredient Abemaciclib, a selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). This stable isotope-labeled compound is essential for precise and reliable quantitative analysis in pharmacokinetic and metabolism studies. It is a critical material for pharmaceutical research and development, particularly for bioanalytical method development and validation in clinical trials.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a stable isotope-labeled internal standard for the accurate quantification of Abemaciclib in biological matrices (e.g., plasma, serum) using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in ADME (Absorption, Distribution, Metabolism, and Excretion) studies to track the parent drug and its metabolites, enabling precise pharmacokinetic modeling.
• Bioanalytical Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA) for clinical trial sample analysis.
• Clinical Research Support: Supports bioanalysis in oncology clinical trials for drugs targeting CDK4/6 pathways, ensuring data integrity and reliability.
• Reference Material for Impurity Profiling: Can be utilized as a reference standard for identifying and characterizing potential deuterated impurities or metabolites in drug substance batches.
• Isotope Dilution Mass Spectrometry (IDMS): Employed in high-precision IDMS techniques for absolute quantification, minimizing matrix effects and ionization variability.

Basic Information

Product Name	Abemaciclib D8
CAS No.	2088650-53-5
Molecular Formula	C27H24D8F N5O4
Molecular Weight	~ 507.6 g/mol
Synonyms	Abemaciclib-d8; N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-(methyl-d3)-1H-benzimidazol-6-yl]-2-pyrimidinamine-d5; LY2835219 D8; Verzenio D8 (deuterated); CDK4/6 Inhibitor D8; Deuterated Abemaciclib; (2-Pyrimidinamine, N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-(methyl-d3)-1H-benzimidazol-6-yl]-, labeled with deuterium)
EINECS	Contact for details

Quality Control

Our Abemaciclib D8 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical identity, which are critical for its role as an analytical standard. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, LC-MS, and HPLC. A comprehensive Certificate of Analysis (COA) is provided, detailing specifications for isotopic enrichment (D8), chemical purity, and identity. Our quality system is designed to support regulatory submissions for clinical research.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive). For long-term storage, keep desiccated under an inert atmosphere. Allow the vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D8)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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