Description

Palbociclib Impurity 3 is a high-purity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Palbociclib. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Palbociclib-related impurities in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating robust HPLC, UPLC, and LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Palbociclib API meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) over time.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the Palbociclib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Palbociclib Impurity 3
CAS No.	2377610-25-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 3; Palbociclib EP Impurity C; Palbociclib USP Impurity; IBRANCE Impurity 3; (2S)-2-[[5-(4-Ethylpiperazin-1-yl)pyridin-2-yl]amino]-8-[5-(1-methylpiperidin-4-yl)pyridin-2-yl]pyrido[2,3-d]pyrimidin-7-one; PF-05212384 Impurity 3
EINECS	Contact for details

Quality Control

Our Palbociclib Impurity 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and ensure high purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and other critical quality attributes. Our quality standards are designed to support compliance with ICH Q3A(R2) and relevant pharmacopeial guidelines for pharmaceutical impurities.

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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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