Description

Mycophenolate Mofetil is a potent immunosuppressive agent, chemically known as the morpholinoethyl ester of mycophenolic acid. This compound is a critical active pharmaceutical ingredient (API) primarily used to prevent organ rejection in transplant patients. It is essential for pharmaceutical manufacturers and research institutions developing immunosuppressive therapies, including tablets, capsules, and intravenous formulations.

Application

• Primary Pharmaceutical Ingredient: Key API in the production of immunosuppressant medications for kidney, heart, and liver transplant recipients.
• Generic Drug Formulation: Serves as the core component for generic versions of branded immunosuppressants.
• Clinical Research: Used in preclinical and clinical studies investigating new immunosuppressive protocols and combination therapies.
• Dosage Form Development: Integral to R&D for developing various oral and injectable dosage forms with controlled release profiles.
• Reference Standard: Employed as a high-purity analytical standard in quality control laboratories for drug testing and verification.

Basic Information

Product Name	Mycophenolate Mofetil
CAS No.	128794-94-5
Molecular Formula	C23H31NO7
Molecular Weight	433.50 g/mol
Synonyms	Mycophenolate Mofetil; MMF; RS-61443; Mycophenolic Acid Morpholinoethyl Ester; (E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic Acid Morpholinoethyl Ester; CellCept (Brand Name); Myfortic (Related Salt); Mycophenolate Sodium (Related Salt)
EINECS	Contact for details

Quality Control

Our Mycophenolate Mofetil is manufactured under strict quality systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis to ensure it meets stringent pharmaceutical-grade specifications. A detailed Certificate of Analysis (COA) is provided with each shipment to guarantee traceability and quality assurance for our B2B partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	≤ 20 ppm

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