Description

Palbociclib Impurity 38 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 enabling accurate identification and quantification during the manufacturing process. It is an essential material for pharmaceutical R&D laboratories, quality assurance/control (QA/QC) units, and regulatory compliance teams working with CDK4/6 inhibitors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Palbociclib API and finished dosage forms.
• Analytical Method Development: Used to establish and calibrate chromatographic methods (HPLC, UPLC) for the precise separation and detection of specific impurities.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker to monitor impurity profiles and degradation pathways in Palbociclib under various stress conditions.
• Process Chemistry Research: Aids in identifying and controlling the formation of this specific impurity during the synthesis and scale-up of Palbociclib.
• Pharmacopoeial Testing: Serves as a critical component for testing against monographs and purity specifications as per ICH guidelines (Q3A, Q3B).

Basic Information

Product Name	Palbociclib Impurity 38
CAS No.	2270982-31-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 38; Palbociclib Impurity RRT 0.xx; 6-Acetyl-8-cyclopentyl-5-methyl-2-[[5-(piperazin-1-yl)pyridin-2-yl]amino]pyrido[2,3-d]pyrimidin-7(8H)-one derivative; IBRANCE Impurity 38; PD-0332991 Impurity 38; CDK4/6 Inhibitor Impurity; Process-related impurity of Palbociclib
EINECS	Contact for details

Quality Control

Every batch of Palbociclib Impurity 38 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to in-house specifications aligned with ICH guidelines.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.