Description

Palbociclib Impurity 61 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 serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of oncology therapeutics.

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.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor impurity levels and ensure compliance with regulatory specifications.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Palbociclib.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity profiles and justify specification limits.
• Research and Development: Aids in process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Palbociclib Impurity 61
CAS No.	2222404-53-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 61; IBRANCE Impurity 61; 6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one; UNII-9K8F8T8A4S; 9K8F8T8A4S; Palbociclib EP Impurity G; Palbociclib USP Impurity 61
EINECS	Contact for details

Quality Control

Our Palbociclib Impurity 61 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, identity confirmation (by IR/LC-MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.