Description

Lenalidomide Impurity 13 is a specified impurity and degradation product of the active pharmaceutical ingredient Lenalidomide. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily used by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Lenalidomide drug products. The availability of a well-characterized impurity standard is essential for compliance with stringent ICH guidelines on impurities in new drug substances.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Lenalidomide Impurity 13 in drug substance and drug product testing.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC/UPLC methods for Lenalidomide, in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Employed in routine quality control laboratories to monitor impurity profiles and ensure batch-to-batch consistency of Lenalidomide API.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and justify specifications.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during the synthesis of Lenalidomide, helping to optimize manufacturing processes.

Basic Information

Item	Detail
Product Name	Lenalidomide Impurity 13
CAS No.	764-28-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenalidomide Related Compound 13; Lenalidomide EP Impurity J; Lenalidomide USP Related Compound J; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione (Degradation Product); Lenalidomide Degradation Product; Lenalidomide Process Impurity; Revlimid Impurity 13
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 13 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, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Handle and store in accordance with good laboratory practices to maintain stability and integrity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 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.