Description

Palbociclib-012 is a high-purity chemical intermediate and reference standard of significant interest in advanced pharmaceutical research and development. This compound is critical for the synthesis and analytical characterization of novel therapeutic agents targeting specific cellular pathways. It is primarily utilized by research institutions, pharmaceutical companies, and contract development and manufacturing organizations (CDMOs) engaged in oncology drug discovery and process chemistry.

Application

• Pharmaceutical Intermediate: Serves as a key building block in the synthesis of active pharmaceutical ingredients (APIs) and novel chemical entities.
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing in pharmaceutical laboratories.
• Biochemical Research: Employed in in vitro studies to investigate kinase inhibition and related cellular mechanisms.
• Process Development: Supports route scouting, optimization, and scale-up activities within process R&D departments.
• Custom Synthesis: A starting material for the preparation of labeled compounds (e.g., deuterated, C13) or structural analogs for structure-activity relationship (SAR) studies.

Basic Information

Product Name	Palbociclib-012
CAS No.	2206135-30-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Impurity 12; Palbociclib Related Compound 12; 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one; UNII-012ABC; Palbociclib-012; Palbociclib EP Impurity J; IBRANCE Impurity 12
EINECS	Contact for details

Quality Control

Our Palbociclib-012 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. We provide full traceability and detailed Certificates of Analysis (COA) that document all critical quality attributes, supporting compliance with cGMP and ICH Q7 guidelines for pharmaceutical intermediates.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
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.