Description

Palbociclib Impurity 59 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 analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of Palbociclib-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Palbociclib API batches.
• Method Development and Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Palbociclib.
• Regulatory Submissions: Provides necessary data on impurity profiles for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Research & Development: Aids in process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Palbociclib Impurity 59
CAS No.	1430196-98-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 59; 6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one; UNII-9F8S6A6D4I; Palbociclib EP Impurity F; Palbociclib Impurity 59 (EP); IBRANCE Impurity 59
EINECS	Contact for details

Quality Control

Every batch of Palbociclib Impurity 59 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic nature, the container must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.