Description

Lenalidomide-D5 is a deuterated analog of the immunomodulatory drug lenalidomide, specifically labeled with five deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical researchers, contract research organizations (CROs), and analytical laboratories engaged in drug development, clinical trials, and regulatory compliance testing for lenalidomide-based therapies.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise quantification of lenalidomide in biological matrices (plasma, serum, urine).
• Drug Metabolism and Pharmacokinetics (DMPK): Used in absorption, distribution, metabolism, and excretion (ADME) studies to track and quantify the parent drug and its metabolites.
• Clinical Trial Support: Enables reliable therapeutic drug monitoring (TDM) and bioequivalence studies during clinical development phases.
• Forensic and Anti-Doping Analysis: Supports accurate detection and quantification in specialized testing environments.
• Reference Material for Method Development: Serves as a certified reference material for developing and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.

Basic Information

Product Name	Lenalidomide-D5
CAS No.	1227162-34-6
Molecular Formula	C13H8D5N3O3
Molecular Weight	264.28 g/mol
Synonyms	3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione-d5; CC-5013-d5; Revlimid-d5; (RS)-3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione-d5; Deuterated Lenalidomide; Lenalidomide (phenyl-d5); Lenalidomide-d5 Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Lenalidomide-D5 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use in regulated environments. Certificates of Analysis (COA) are supplied with each shipment, detailing critical parameters such as isotopic purity, chemical purity, and absence of interfering impurities. Our quality commitment ensures compliance with the standards expected for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 95.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 1.0%

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