Description

Palbociclib Impurity 9 is a specified impurity of Palbociclib, a critical active pharmaceutical ingredient (API) used in targeted cancer therapy. This compound is essential for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Palbociclib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Palbociclib Impurity 9 in Palbociclib API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing and validating stability-indicating methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Batch Release Testing: Employed in routine QC testing of Palbociclib to ensure compliance with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Palbociclib to minimize the formation of this impurity.

Basic Information

Product Name	Palbociclib Impurity 9
CAS No.	2204368-66-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 9; 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 9; PD-0332991 Impurity 9
EINECS	Contact for details

Quality Control

Our Palbociclib Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines to support your regulatory and research 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 or COA. 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 (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Assay	Contact for details
Related Substances (HPLC)	Contact for details
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	Contact for details

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