Description

Mycophenolic Acid Glucuronide is a primary, pharmacologically inactive metabolite of the immunosuppressant drug mycophenolate mofetil. This compound is of critical importance for pharmaceutical research and development, serving as a key reference standard and analytical marker. It is essential for scientists and quality control laboratories in the pharmaceutical and biotechnology sectors who require precise analytical tools for drug metabolism studies, bioanalytical method validation, and therapeutic drug monitoring.

Application

• Pharmaceutical Reference Standard: Primary application as a certified reference material (CRM) for the quantification and qualification of mycophenolic acid and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in in vitro and in vivo studies to understand the metabolic pathway, clearance, and exposure of mycophenolic acid-based therapeutics.
• Bioanalytical Method Development & Validation: Critical for developing and validating robust HPLC, LC-MS/MS, or UPLC methods for clinical and preclinical sample analysis.
• Therapeutic Drug Monitoring (TDM): Serves as a calibration standard in assays used to monitor drug levels in transplant patients to optimize efficacy and minimize toxicity.
• Impurity Profiling: Used to identify and quantify this specific glucuronide metabolite as a potential impurity in active pharmaceutical ingredient (API) batches of mycophenolate mofetil or mycophenolic acid.
• Clinical Research: Employed in studies investigating the correlation between metabolite levels and clinical outcomes or adverse events in patients.

Basic Information

Product Name	Mycophenolic Acid Glucuronide
CAS No.	31528-44-6
Molecular Formula	C24H30O13
Molecular Weight	526.49 g/mol
Synonyms	Mycophenolic Acid β-D-Glucuronide; Mycophenolic Acid Glucuronide (MPAG); 7-(β-D-Glucopyranuronosyl)mycophenolic Acid; Mycophenolate Glucuronide; 4-Methyl-6-(1,3-dihydro-7-hydroxy-5-methoxy-4-oxo-1-isobenzofuranyl)-4-hexenoic Acid 7-(β-D-Glucopyranosiduronate); Phenolic Acid Glucuronide; MPAG; ERL-968 (minor metabolite)
EINECS	Contact for details

Quality Control

Our Mycophenolic Acid Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (NMR, IR, MS) and purity determination by validated chromatographic methods (HPLC, LC-MS). We provide full traceability and Certificates of Analysis (COA) detailing batch-specific results for identity, assay, purity, and residual solvents, ensuring compliance with research and quality control standards.

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 should be handled in a dry environment to maintain stability and purity. Keep container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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