Description

Lenalidomide Impurity 17 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 used by analytical chemists, quality assurance professionals, and researchers in pharmaceutical companies and contract research organizations (CROs) to ensure the purity, safety, and efficacy of lenalidomide-based drug products.

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 QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with regulatory specifications (ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data on impurity characterization for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of lenalidomide.

Basic Information

Product Name	Lenalidomide Impurity 17
CAS No.	1198299-50-1
Molecular Formula	C13H13N3O3
Molecular Weight	259.26 g/mol
Synonyms	Lenalidomide Related Compound 17; Lenalidomide EP Impurity 17; Lenalidomide USP Impurity 17; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione; 2-(2,6-Dioxopiperidin-3-yl)-4-amino-1H-isoindole-1,3(2H)-dione; Lenalidomide Degradant; Lenalidomide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 17 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 standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to client specifications or in-house reference standards.

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 must be kept under inert conditions or in a desiccator to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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