Description

Palbociclib Impurity 8 is a specified impurity of Palbociclib, a critical active pharmaceutical ingredient used in targeted cancer therapy. This compound is essential for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Palbociclib drug substances and products. It is primarily required by analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical manufacturing and contract research organizations to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Palbociclib Impurity 8 in drug substance and finished product analysis.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Palbociclib.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure batch-to-batch consistency.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Palbociclib to minimize the formation of this impurity.

Basic Information

Product Name	Palbociclib Impurity 8
CAS No.	827022-31-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one; Palbociclib Related Compound 8; IBRANCE Impurity 8; PF-05280014 Impurity; (S)-6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one
EINECS	Contact for details

Quality Control

Every batch of Palbociclib Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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