Description

Mycophenolate Mofetil CAS NO 115007-34-6 is a potent immunosuppressive agent, chemically known as the 2-morpholinoethyl ester of mycophenolic acid. This compound is critical for preventing organ rejection in transplant patients by selectively inhibiting inosine monophosphate dehydrogenase, a key enzyme in the de novo pathway of guanosine nucleotide synthesis. It is an essential active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers for the production of immunosuppressive medications.

Application

• Primary Pharmaceutical Ingredient: Core active component in immunosuppressive drugs for organ (kidney, heart, liver) transplantation.
• Autoimmune Disease Therapy: Used in the formulation of medications for treating conditions like lupus and psoriasis.
• Generic Drug Manufacturing: Sourced by generic pharmaceutical companies for cost-effective alternative formulations.
• Clinical Research & Development: Utilized in preclinical and clinical studies for new immunosuppressive therapies.
• Dosage Form Production: Essential for manufacturing various dosage forms including tablets, capsules, and intravenous solutions.
• Reference Standard: Serves as a high-purity analytical standard for quality control laboratories.

Basic Information

Product Name	Mycophenolate Mofetil
CAS No.	115007-34-6
Molecular Formula	C23H31NO7
Molecular Weight	433.50 g/mol
Synonyms	Mycophenolate Mofetil; MMF; RS-61443; Mycophenolic Acid 2-Morpholinoethyl Ester; CellCept (Brand Name); Myfortic (Related Salt); (E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid 2-Morpholinoethyl Ester; 2-Morpholin-4-ylethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoate
EINECS	Contact for details

Quality Control

Our Mycophenolate Mofetil is manufactured under strict quality systems to meet the rigorous standards of the pharmaceutical industry. We ensure compliance with relevant pharmacopoeial specifications, including USP and EP monographs. Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, confirming its suitability for use as an active pharmaceutical ingredient (API).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This 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
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.