Description

Lenalidomide Impurity 23 is a specified impurity associated with the active pharmaceutical ingredient lenalidomide. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of lenalidomide-based drug products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in lenalidomide API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Used in stability studies to monitor impurity profiles and degradation pathways of lenalidomide under various storage conditions.
• Critical for regulatory compliance and submissions (e.g., FDA, EMA) requiring detailed impurity characterization.
• Supports pharmaceutical research into the synthesis, metabolism, and pharmacokinetics of lenalidomide.
• Employed in the calibration of laboratory equipment to ensure accurate and reproducible analytical results.

Basic Information

Product Name	Lenalidomide Impurity 23
CAS No.	6810-78-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenalidomide Related Compound 23; Lenalidomide EP Impurity J; Lenalidomide USP Impurity; 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione derivative; Lenalidomide Process Impurity; Lenalidomide Degradant; Lenalidomide Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and relevant pharmacopoeial standards (USP, EP) for impurity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
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.