Description

Mycophenolic Acid Acyl-B-D-Glucuronide is a key metabolite and reference standard for the immunosuppressant drug mycophenolate mofetil. This compound is critical for pharmaceutical research, development, and quality control, enabling precise pharmacokinetic and metabolic studies. It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in drug metabolism, bioequivalence testing, and the production of generic immunosuppressive therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of mycophenolic acid metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK): Essential for studying the metabolic pathways, bioavailability, and clearance of mycophenolate mofetil and related drugs.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, and LC-MS/MS methods for therapeutic drug monitoring (TDM).
• Impurity Profiling: Employed in the identification and quantification of process-related impurities and degradation products in active pharmaceutical ingredient (API) batches.
• Clinical Research: Supports studies investigating patient variability, drug-drug interactions, and the correlation of metabolite levels with efficacy or toxicity.
• Regulatory Compliance & Quality Control: A vital component for ensuring batch-to-batch consistency and meeting regulatory submission requirements from agencies like the FDA and EMA.

Basic Information

Product Name	Mycophenolic Acid Acyl-B-D-Glucuronide
CAS No.	99043-04-6
Molecular Formula	C24H28O12
Molecular Weight	508.47 g/mol
Synonyms	MPA Acyl Glucuronide; Mycophenolic Acid Glucuronide; Mycophenolic Acid β-D-Glucuronide; 7-O-Mycophenolyl-β-D-glucuronide; AcMPAG; Acyl-MPA-Glucuronide; (E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid β-D-glucopyranosiduronic acid
EINECS	Contact for details

Quality Control

Our Mycophenolic Acid Acyl-B-D-Glucuronide is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, controlled environment. This product is hygroscopic (moisture-sensitive) and should be allowed to equilibrate to room temperature in a desiccator before opening to prevent condensation and degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (Mass Spectrometry)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH guidelines

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