Description

Azathioprine-13C4 is a stable isotope-labeled analog of the immunosuppressive drug azathioprine, where four carbon atoms are replaced with the 13C isotope. This compound is a critical internal standard for the precise and accurate quantification of azathioprine in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is an essential tool for pharmaceutical research and development, clinical laboratories, and forensic toxicology studies requiring high-fidelity data. Professionals in pharmacokinetics, bioequivalence testing, and drug metabolism rely on this labeled standard to ensure analytical method validity and regulatory compliance.

Application

• Quantitative Bioanalysis: Serves as an internal standard for the LC-MS/MS quantification of azathioprine in plasma, serum, and urine for pharmacokinetic (PK) and toxicokinetic (TK) studies.
• Clinical Research & Therapeutic Drug Monitoring (TDM): Enables accurate measurement of drug concentrations in patient samples to optimize dosing regimens and minimize toxicity.
• Pharmaceutical R&D: Used in drug metabolism and disposition (DMPK) studies to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of azathioprine.
• Forensic and Anti-Doping Analysis: Provides a reliable reference for the confirmatory identification and quantification of azathioprine in forensic toxicology and sports doping control.
• Method Development & Validation: Critical for developing, validating, and transferring robust analytical methods in compliance with FDA, EMA, and ICH guidelines (e.g., ICH M10).
• Manufacturing Quality Control: Supports impurity profiling and assay verification during the manufacturing process of azathioprine-based pharmaceutical products.

Basic Information

Item	Detail
Product Name	Azathioprine-13C4
CAS No.	1346600-71-2
Molecular Formula	C913C4H7N7O2S
Molecular Weight	281.28 (based on 13C=13.0034)
Synonyms	6-[(1-Methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine-13C4; Azathioprine (13C4); 13C4-Azathioprine; Azathioprine-13C4 Internal Standard; Azathioprine Stable Isotope Labeled; Imuran-13C4 (labeled analog); AZA-13C4; 6-[(1-Methyl-4-nitroimidazol-5-yl)sulfanyl]-7H-purine-13C4
EINECS	Contact for details

Quality Control

Every batch of Azathioprine-13C4 is manufactured and analyzed under strict quality systems to ensure the highest standards of isotopic purity and chemical identity. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request and provide comprehensive data, including isotopic enrichment (atom % 13C) confirmed by NMR and MS, chemical purity by HPLC, and confirmation of structure.

Storage

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

Specification

Item	Specification
Appearance	Yellow to pale yellow powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity	≥99 atom % 13C
Isotopic Enrichment	≥98% (13C4)
Water Content (KF)	≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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