Description

Palbociclib Impurity 23 is a designated impurity reference 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 providing a benchmark for identification and quantification during HPLC and LC-MS analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams involved in the development and manufacturing of Palbociclib-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of specific impurities in Palbociclib API and drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods (HPLC, UPLC, LC-MS) in compliance with ICH guidelines.
• Quality Control and Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure batch-to-batch consistency meets pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation and growth of this impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles, specifications, and control strategies in New Drug Applications (NDAs).
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during API synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Palbociclib Impurity 23
CAS No.	2205035-04-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 23; IBRANCE Impurity 23; PD-0332991 Impurity 23; 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 Specified Impurity 23
EINECS	Contact for details

Quality Control

Every batch of Palbociclib Impurity 23 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, related substance analysis, and other relevant spectroscopic data (NMR, MS). We support compliance with ICH Q3A, Q3B, and Q6A guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under 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)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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