Description

Palbociclib Impurity n-Oxide is a specified impurity and degradation product of Palbociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor used in cancer therapy. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, stability studies, and quality control of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Palbociclib-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Palbociclib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways and stability profile of Palbociclib.
• Quality Control & Batch Release: A critical component in the quality control process to monitor impurity levels and ensure compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research on Degradation Chemistry: Used in academic and industrial research to study the oxidation mechanisms and metabolic pathways of Palbociclib.

Basic Information

Item	Details
Product Name	Palbociclib Impurity n-Oxide
CAS No.	2174002-29-8
Molecular Formula	C24H29N7O3
Molecular Weight	463.54 g/mol
Synonyms	6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one 1-Oxide; Palbociclib N-Oxide; Palbociclib Related Compound n-Oxide; IBRANCE Impurity n-Oxide; PD-0332991 Impurity n-Oxide; (S)-6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8H-pyrido[2,3-d]pyrimidin-7-one N-Oxide
EINECS	Contact for details

Quality Control

Every batch of Palbociclib Impurity n-Oxide is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for structural confirmation, and NMR for identity verification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is light-sensitive (store away from light). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent further oxidation.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.