Description

Ribociclib Impurity 2 (n-Desmethyl Ribociclib) is a key process-related impurity and metabolite of the active pharmaceutical ingredient Ribociclib, a CDK4/6 inhibitor used in cancer therapy. This compound is essential for pharmaceutical research and development, serving as a critical reference standard for method development, stability studies, and regulatory compliance. It is primarily required by analytical laboratories, quality control units, and research scientists in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Ribociclib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of n-Desmethyl Ribociclib in Ribociclib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor and control impurity profiles during manufacturing.
• Stability Studies & Forced Degradation: Employed to understand degradation pathways and establish shelf-life specifications for Ribociclib formulations.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Metabolite Research: Serves as a reference compound for in-vitro and in-vivo metabolism studies to understand the pharmacokinetic profile of Ribociclib.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure API and drug product batches meet stringent purity specifications.

Basic Information

Product Name	Ribociclib Impurity 2 (n-Desmethyl Ribociclib)
CAS No.	1211441-59-6
Molecular Formula	C22H28N8O
Molecular Weight	420.52 g/mol
Synonyms	LEE011 Impurity 2; N-Desmethyl Ribociclib; 7-Cyclopentyl-N,N-dimethyl-2-[[5-(1-piperazinyl)-2-pyridinyl]amino]-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide; Ribociclib Desmethyl Impurity; Ribociclib Related Compound 2; Kisqali Impurity 2; LEE011 N-Desmethyl Metabolite
EINECS	Contact for details

Quality Control

Our Ribociclib Impurity 2 is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes rigorous analytical testing, including HPLC purity determination, LC-MS confirmation, and NMR structural verification, to ensure identity, purity, and consistency. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards. Our quality commitment aligns with the standards expected for ICH guidelines Q3A(R2) and Q3B(R2) on impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, or as indicated on the label or certificate of analysis. For long-term storage, keep the container in a cool, dry, well-ventilated area. The product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
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.