Description

Palbociclib Impurity 21 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 for method development, validation, and quality control during drug substance and product manufacturing. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Palbociclib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles throughout the product lifecycle.
• Quality Control & Batch Release: Employed in routine QC testing to ensure impurity levels in commercial batches comply with International Council for Harmonisation (ICH) Q3A/B guidelines.
• Stability Studies: Used to track the formation and growth of this impurity under various stress conditions (thermal, photolytic, hydrolytic) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Palbociclib Impurity 21
CAS No.	2098673-40-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 21; IBRANCE Impurity 21; 6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one (IUPAC-based); PD-0332991 Impurity 21; CDK4/6 Inhibitor Impurity 21; (2S)-2-{[5-(4-Acetylpiperazin-1-yl)pyridin-2-yl]amino}-8-cyclopentyl-5-methylpyrido[2,3-d]pyrimidin-7(8H)-one derivative
EINECS	Contact for details

Quality Control

Every batch of Palbociclib Impurity 21 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing batch-specific results, analytical methods, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term storage, desiccate at -20°C. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to 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.