Description

Palbociclib Impurity 87 is a designated impurity 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 providing a reference for identification and quantification during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams working on oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Method Development and Validation: Used in the development and validation of HPLC, UPLC, and LC-MS methods for Palbociclib analysis.
• Quality Control and Batch Release: Essential for the routine testing of Palbociclib API and drug products to monitor and control impurity levels as per ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions during drug stability testing.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., with the FDA, EMA) to establish impurity profiles.
• Process Chemistry Research: Aids in the optimization of synthetic routes by identifying and quantifying process-related impurities.

Basic Information

Item	Details
Product Name	Palbociclib Impurity 87
CAS No.	571189-51-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 87; IBRANCE Impurity 87; PF-05212384 Impurity; (S)-6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8H-pyrido[2,3-d]pyrimidin-7-one; UNII-7Q8I6QZ2VK
EINECS	Contact for details

Quality Control

Our Palbociclib Impurity 87 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (by IR and/or MS), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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