Description

Lenalidomide Impurity 22 is a specified impurity of the active pharmaceutical ingredient Lenalidomide, a critical immunomodulatory drug. This compound is essential for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Lenalidomide drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

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.
• Method Development & Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial limits.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Lenalidomide.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Process Chemistry Research: Aids in understanding the synthetic pathway of Lenalidomide and optimizing manufacturing processes to minimize impurity formation.

Basic Information

Item	Details
Product Name	Lenalidomide Impurity 22
CAS No.	1240215-87-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenalidomide Related Compound 22; Lenalidomide Impurity K; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione derivative; Lenalidomide Process Impurity; Lenalidomide Degradant; CC-5013 Impurity 22; Revlimid® Impurity 22
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 22 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, and MS to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is light-sensitive and should be handled accordingly to maintain stability.

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)	Meets internal specifications
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.