Description

Mycophenolate Mofetil-D4 is a deuterated internal standard of the immunosuppressive drug Mycophenolate Mofetil, essential for precise quantitative analysis. This stable isotope-labeled compound is critical for ensuring accuracy and reliability in pharmacokinetic and bioanalytical studies. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for method development and validation in drug metabolism and therapeutic drug monitoring.

Application

• Bioanalytical Reference Standard: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS) for quantifying Mycophenolate Mofetil and its metabolites in biological matrices.
• Pharmacokinetic Studies: Enables accurate measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and preclinical research.
• Therapeutic Drug Monitoring (TDM): Used in the development and validation of assays to monitor drug concentrations in patient plasma or serum, optimizing immunosuppressive therapy.
• Drug Metabolism Research: Facilitates the identification and quantification of drug metabolites, aiding in the understanding of metabolic pathways.
• Method Development & Validation: Provides a stable, non-interfering standard for developing robust and compliant analytical methods according to FDA, EMA, and ICH guidelines.
• Quality Control & Assurance: Employed in pharmaceutical manufacturing for in-process testing and final product release to ensure batch consistency and potency.

Basic Information

Product Name	Mycophenolate Mofetil-D4
CAS No.	1132748-21-0
Molecular Formula	C23H27D4NO7
Molecular Weight	Approx. 437.5 g/mol
Synonyms	Mycophenolate Mofetil-d4; 2-Morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate-d4; MMF-d4; Mycophenolic Acid 2-Morpholinoethyl Ester-d4; RS-61443-d4; CellCept-d4 (deuterated analog); (E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid 2-morpholinoethyl ester-d4
EINECS	Contact for details

Quality Control

Our Mycophenolate Mofetil-D4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including NMR, HPLC, and MS, to confirm isotopic purity, chemical purity, and identity. Certificates of Analysis (COA) detailing batch-specific results are provided and comply with relevant standards for reference materials. We support method development aligned with ICH Q2(R1), FDA, and EMA guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0% (Chemical Purity)
Isotopic Purity (MS)	≥98.0 atom % D
Chemical Purity (HPLC)	≥98.0%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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