Description

Lenalidomide Impurity 1 is a specified impurity associated with the active pharmaceutical ingredient lenalidomide, a critical immunomodulatory drug. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by analytical chemists, quality assurance professionals, and regulatory affairs specialists within the pharmaceutical and biotechnology sectors 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 drug substance and finished products.
• 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 testing to monitor and control impurity levels, ensuring compliance with 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 regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Research & Development: Supports synthetic route optimization and process chemistry by identifying and characterizing process-related impurities.

Basic Information

Item	Details
Product Name	Lenalidomide Impurity 1
CAS No.	2197420-75-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenalidomide Related Compound 1; Lenalidomide Impurity; Lenalidomide Specified Impurity 1; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione derivative; Revlimid Impurity 1; CC-5013 Impurity 1
EINECS	Contact for details

Quality Control

Our Lenalidomide Impurity 1 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, GC, MS, and NMR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and traceability. Our quality commitment aligns with ICH guidelines and relevant pharmacopeial standards to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed and may require desiccant. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.