Description

Palbociclib Impurity 7 CAS NO 2204442-50-0 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Palbociclib, a critical oncology drug. This impurity is essential for method validation, stability studies, and ensuring the safety and efficacy of the final drug product by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, production, and compliance testing of Palbociclib API and its formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Palbociclib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to ensure specificity, accuracy, and robustness in impurity profiling.
• Stability and Forced Degradation Studies: Used to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life and storage guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to confirm that Palbociclib batches meet stringent impurity limits as per ICH guidelines and regulatory submissions.
• Regulatory Compliance & Filing: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand impurity formation pathways and to develop purer synthesis routes for Palbociclib.

Basic Information

Product Name	Palbociclib Impurity 7
CAS No.	2204442-50-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 7; IBRANCE Impurity 7; PD-0332991 Impurity 7; 6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one Impurity; Palbociclib EP Impurity G; Palbociclib USP Impurity; (S)-Palbociclib Impurity
EINECS	Contact for details

Quality Control

Every batch of Palbociclib Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified 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.