Description

Palbociclib Impurity I is a specified impurity associated with the active pharmaceutical ingredient Palbociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor. This compound is critical 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 utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

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.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity profiles and ensure the drug substance meets predefined specification limits.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Palbociclib.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Research and Development: Supports synthetic route optimization and process chemistry by helping to identify and control process-related impurities.

Basic Information

Product Name	Palbociclib Impurity I
CAS No.	2172256-78-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound I; Palbociclib Impurity 1; 6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one; IBRANCE Impurity I; CDK 4/6 Inhibitor Impurity I; PD-0332991 Impurity I
EINECS	Contact for details

Quality Control

Our Palbociclib Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and chromatographic data. Our quality commitment aligns with cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.