Description

Palbociclib Impurity 33 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 reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Palbociclib drug substances and 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: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions.
• 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 33
CAS No.	1974279-40-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 33; Palbociclib EP Impurity 33; Palbociclib USP Impurity 33; IBRANCE Impurity 33; 6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one (Related Impurity); PF-05212384 Impurity 33; PD-0332991 Impurity 33
EINECS	Contact for details

Quality Control

Our Palbociclib Impurity 33 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, residual solvent analysis (GC), and structural confirmation (NMR, MS) to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data, supporting compliance with ICH and GMP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccator or under an inert atmosphere after opening to prevent moisture absorption, which may affect stability and purity.

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%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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