Description

Palbociclib Impurity 33 (CAS NO 2363160-84-1) is a high-purity reference standard used in the analytical profiling 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 accurately identifying and quantifying related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the development and manufacturing of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Palbociclib API and finished dosage forms.
• Method Development & Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure batches meet stringent pharmacopeial (USP, EP) and internal specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Supports impurity characterization, route scouting, and process chemistry optimization during API synthesis development.

Basic Information

Product Name	Palbociclib Impurity 33
CAS No.	2363160-84-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palbociclib Related Compound 33; Palbociclib EP Impurity I; IBRANCE Impurity 33; 6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one; UNII-9J8F7859PJ; 9J8F7859PJ
EINECS	Contact for details

Quality Control

Our Palbociclib Impurity 33 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with high-grade reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 under inert conditions or in a desiccator after opening to maintain stability and purity.

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)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Water Content (KF)	≤ 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.