Description

Lenalidomide Impurity 19 is a specified impurity and degradation product of the active pharmaceutical ingredient Lenalidomide, a critical immunomodulatory drug. This compound is essential for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control testing. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the global pharmaceutical and biotechnology industries to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lenalidomide API and finished dosage forms.
• Analytical Method Development: Critical for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity levels against ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Lenalidomide.

Basic Information

Product Name	Lenalidomide Impurity 19
CAS No.	827026-44-8
Molecular Formula	C13H13N3O3
Molecular Weight	259.26 g/mol
Synonyms	Lenalidomide Related Compound 19; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; Lenalidomide Impurity; Lenalidomide Degradation Product; Lenalidomide EP Impurity 19; Lenalidomide USP Impurity 19; Revlimid Impurity 19; CC-5013 Impurity 19
EINECS	Contact for details

Quality Control

Our Lenalidomide Impurity 19 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with relevant standards. Our quality commitment ensures material suitable for use in GMP-regulated environments and for supporting regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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