Description

Mycophenolate Methyl Ester is a potent and specific immunosuppressive agent, chemically known as the methyl ester derivative of mycophenolic acid. Its primary value lies in its ability to selectively inhibit inosine monophosphate dehydrogenase, a key enzyme in the de novo pathway of guanosine nucleotide synthesis, which is crucial for lymphocyte proliferation. This makes it an essential active pharmaceutical ingredient (API) for the formulation of immunosuppressant drugs, primarily targeting the pharmaceutical industry for the prevention of organ transplant rejection and the treatment of autoimmune diseases.

Application

• Primary Pharmaceutical Ingredient: Core active component in immunosuppressant medications for organ transplantation (kidney, heart, liver).
• Autoimmune Disease Therapy: Used in the formulation of drugs for treating conditions like lupus, psoriasis, and rheumatoid arthritis.
• Generic Drug Manufacturing: Serves as a key starting material for the production of generic mycophenolate mofetil formulations.
• Clinical Research & Development: Utilized in preclinical and clinical studies for developing new immunosuppressive therapies.
• Reference Standard: Acts as a high-purity chemical standard for quality control and analytical testing in pharmaceutical labs.
• Dosage Form Development: Employed in R&D for creating various dosage forms, including tablets and capsules.

Basic Information

Product Name	Mycophenolate Methyl Ester
CAS No.	24243-40-1
Molecular Formula	C23H31NO7
Molecular Weight	433.50 g/mol
Synonyms	Mycophenolate Mofetil; MMF; RS-61443; (E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid Methyl Ester; 2-Morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate; CellCept (Brand Name); Mycophenolic Acid 2-Morpholinoethyl Ester
EINECS	Contact for details

Quality Control

Our Mycophenolate Methyl Ester is manufactured under strict quality management systems, targeting specifications that meet or exceed major pharmacopeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, to ensure high purity and consistent performance. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with agreed specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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