Description

Lenalidomide Impurity 2 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) lenalidomide. This compound is critical for ensuring the purity, safety, and efficacy of lenalidomide-based drug products by serving as a benchmark in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams 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 lenalidomide API and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC).
• Stability Studies: Employed to monitor the formation of degradation products in lenalidomide under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Filing: Used to generate data for regulatory submissions (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Quality Control Testing: Routinely used in in-process control (IPC) and release testing of lenalidomide batches to ensure compliance with pharmacopeial standards (USP, EP).
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Lenalidomide Impurity 2
CAS No.	874760-69-7
Molecular Formula	C13H10N4O3
Molecular Weight	270.24 g/mol
Synonyms	3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; Lenalidomide Impurity B; Lenalidomide Related Compound B; Lenalidomide EP Impurity B; Lenalidomide USP Impurity; CC-5013 Impurity; Revlimid® Impurity
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial and in-house specifications. 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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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