Description

Palbociclib Impurity 14 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Palbociclib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of Palbociclib, a CDK4/6 inhibitor used in cancer therapy.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Palbociclib API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for Palbociclib.
• Essential for quality control and release testing of Palbociclib drug substance and drug products to meet ICH guidelines.
• Used in stability studies to monitor impurity profiles over time under various storage conditions.
• Serves as a system suitability standard in regulatory submissions (e.g., to FDA, EMA) for drug approval dossiers.
• Supports research and development activities aimed at understanding the degradation pathways of Palbociclib.

Basic Information

Product Name	Palbociclib Impurity 14
CAS No.	51534-87-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 14; Palbociclib EP Impurity 14; Palbociclib USP Impurity 14; IBRANCE Impurity 14; (2S)-2-[5-(1-Piperazinyl)-2H-pyrazol-3-yl]amino]-N-[5-(4-methyl-1-piperazinyl)-2-pyridinyl]-5-pyrimidinecarboxamide; A potential process-related impurity of Palbociclib.
EINECS	Contact for details

Quality Control

Every batch of Palbociclib Impurity 14 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using validated chromatographic (HPLC) and spectroscopic methods to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.