Description

Palbociclib Impurity 7 (CAS NO 827022-35-5) is a specified impurity and degradation product 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 key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis, purification, and regulatory compliance 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: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) for drug product stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify specifications.
• Process Chemistry Research: Aids in optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Palbociclib Impurity 7
CAS No.	827022-35-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 7; Palbociclib Impurity C; 6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one; IBRANCE Impurity 7; PD-0332991 Impurity 7; CDK 4/6 Inhibitor Impurity; (S)-Pyrido[2,3-d]pyrimidin-7(8H)-one derivative (Palbociclib related)
EINECS	Contact for details

Quality Control

Our Palbociclib Impurity 7 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic characterization (NMR, MS), to ensure identity, strength, and composition. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles for pharmaceutical reference standards, supporting your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.