Description

Abemaciclib Metabolites M2 is a key pharmacologically active metabolite of the oncology drug Abemaciclib, identified by CAS number 1231930-57-6. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in the development and quality control of cyclin-dependent kinase (CDK) 4 & 6 inhibitor therapies.

Application

• Reference Standard for Bioanalysis: Serves as a critical certified reference material (CRM) for the quantification of Abemaciclib and its metabolites in biological matrices (plasma, serum) using LC-MS/MS methods.
• Pharmacokinetic (PK) and Metabolism Studies: Used to investigate the metabolic pathways, clearance rates, and exposure levels of Abemaciclib in preclinical and clinical studies.
• Drug Impurity Profiling: Employed as an impurity standard to monitor and control the levels of metabolite M2 in the active pharmaceutical ingredient (API) and finished drug product to ensure safety and efficacy.
• Regulatory Submissions: Provides essential data for Investigational New Drug (IND) and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• In-vitro Research: Supports in-vitro studies to understand the activity and potency of the metabolite compared to the parent drug.
• Method Development and Validation: A crucial component for developing, qualifying, and validating robust analytical methods in compliance with ICH Q2(R1) guidelines.

Basic Information

Product Name	Abemaciclib Metabolites M2
CAS No.	1231930-57-6
Molecular Formula	C27H32F2N8O
Molecular Weight	510.59 g/mol
Synonyms	Abemaciclib Metabolite M2; Abemaciclib M2; N-Desethyl Abemaciclib; N-Deethyl Abemaciclib; LY2835219 Metabolite M2; (S)-N-(5-((4-Ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(7-fluoro-2-(1H-indazol-5-yl)quinolin-4-ylamino)-2-methylbenzamide; 5-fluoro-N-[5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl]-4-[7-fluoro-2-(1H-indazol-5-yl)quinolin-4-yl]amino]-2-methylbenzamide
EINECS	Contact for details

Quality Control

Our Abemaciclib Metabolites M2 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) containing detailed chromatographic data, batch-specific results, and storage recommendations are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (Mass Spectrometry)	Consistent with molecular structure
Purity (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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