Description

Abemaciclib Impurity 6 is a specified impurity of the active pharmaceutical ingredient Abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Abemaciclib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Abemaciclib API and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification of Abemaciclib.

Basic Information

Product Name	Abemaciclib Impurity 6
CAS No.	1528469-78-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Abemaciclib Related Compound 6; Abemaciclib EP Impurity 6; Abemaciclib USP Impurity 6; LY2835219 Impurity 6; Verzenio Impurity 6; (2S)-2-({5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl}amino)-8-fluoro-4-methyl-3,4-dihydro-2H-pyrido[4,3-b][1,4]oxazin-5(6H)-one Impurity; Abemaciclib Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Abemaciclib Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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