Description

Palbociclib Impurity D is a specified impurity of Palbociclib, a critical active pharmaceutical ingredient (API) used in targeted cancer therapy. This compound is essential for pharmaceutical research, development, and quality control, serving as a certified reference standard to ensure the purity, safety, and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis and quality assurance of Palbociclib API and its formulations.

Application

• As a certified reference standard for the identification and quantification of Palbociclib Impurity D in Palbociclib API and drug products.
• For method development and validation in analytical techniques such as HPLC, UPLC, and LC-MS.
• In pharmaceutical research to study the degradation pathways and stability profile of Palbociclib.
• For quality control (QC) and quality assurance (QA) processes in GMP-compliant manufacturing facilities.
• As a critical component in regulatory submissions (e.g., to FDA, EMA) to establish impurity profiles and specifications.
• Used in stability studies to monitor impurity levels over the shelf-life of the drug product.

Basic Information

Product Name	Palbociclib Impurity D
CAS No.	850918-83-1
Molecular Formula	C24H29N7O2
Molecular Weight	447.54 g/mol
Synonyms	6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one; Palbociclib Related Compound D; IBRANCE Impurity D; PD-0332991 Impurity D; (S)-6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one; PF-00080665-05; UNII-9J97361D4P
EINECS	Contact for details

Quality Control

Our Palbociclib Impurity D is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, supporting compliance with ICH Q3A/B guidelines and regulatory requirements for drug substance impurities.

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 COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.