Description

Rac Lenalidomide-13C5 is a stable isotope-labeled analog of the immunomodulatory drug lenalidomide, where five carbon atoms are replaced with the carbon-13 (13C) isotope. This compound is essential as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolomic studies. It is a critical tool for pharmaceutical researchers, contract research organizations (CROs), and analytical laboratories engaged in drug development, clinical trial support, and regulatory compliance testing for lenalidomide and related compounds.

Application

• Internal Standard for LC-MS/MS: Primary use as a quantitative internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise measurement of lenalidomide in biological matrices (plasma, serum, urine).
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles during preclinical and clinical development stages.
• Clinical Trial Bioanalysis: Supports robust and GLP-compliant bioanalytical method development and validation for therapeutic monitoring in clinical studies.
• Metabolite Identification: Aids in the structural elucidation and quantification of lenalidomide metabolites using advanced mass spectrometry techniques.
• Reference Material for Method Development: Serves as a certified reference material for establishing and calibrating analytical methods in quality control laboratories.
• Regulatory Submissions: Provides the data integrity required for supporting regulatory filings with agencies such as the FDA and EMA.

Basic Information

Product Name	Rac Lenalidomide-13C5
CAS No.	1219332-91-8
Molecular Formula	C1313C5H12N4O3
Molecular Weight	265.23 g/mol (for 13C5 labeled form)
Synonyms	Lenalidomide-13C5; (RS)-Lenalidomide-13C5; 3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione-13C5; Revlimid-13C5 (labeled analog); CC-5013-13C5; CDC 501-13C5; Isotopically Labeled Lenalidomide; [13C5]-Lenalidomide
EINECS	Contact for details

Quality Control

Every batch of Rac Lenalidomide-13C5 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, HPLC, and Mass Spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of interfering impurities. Our quality commitment ensures the material meets the stringent requirements for use in regulated bioanalytical research.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC-MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (13C)	≥ 99 atom % 13C
Isotopic Enrichment	≥ 95% 13C5
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.5%

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