Mycophenolate Mofetil is a synthetic immunosuppressive active pharmaceutical ingredient (API) used in the development and manufacture of pharmaceutical formulations for immunosuppression. It is the 2-morpholinoethyl ester prodrug of mycophenolic acid (MPA), which inhibits inosine monophosphate dehydrogenase and suppresses the proliferation of activated T and B lymphocytes.
Mycophenolate Mofetil has CAS Number 128794-94-5, molecular formula C23H31NO7, and molecular weight 433.50 g/mol.
Mycophenolate Mofetil is an established immunosuppressive pharmaceutical API used primarily in the development of oral formulations. Its quality evaluation includes identification, assay, related substances, water content, residual solvents and other applicable pharmaceutical quality attributes.
CAS Number: 128794-94-5
Molecular Formula: C23H31NO7
Molecular Weight: 433.50 g/mol
Chemical Name: 2-Morpholin-4-ylethyl (4E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-2-benzofuran-5-yl)-4-methylhex-4-enoate
Drug Class: Immunosuppressant
Therapeutic Class: Immunosuppressive Agent
Therapeutic Area: Transplantation / Immunology
Molecule Type: Synthetic Small Molecule
Mycophenolate Mofetil is rapidly converted to mycophenolic acid, its active metabolite. Mycophenolic acid selectively inhibits inosine monophosphate dehydrogenase (IMPDH), an enzyme required for de novo guanosine nucleotide synthesis.
This mechanism results in:
Mycophenolate Mofetil API is used in the development and manufacture of formulations for:
Mycophenolate Mofetil is particularly important in transplantation medicine because lymphocytes depend substantially on the de novo pathway for purine synthesis. Inhibition of IMPDH by its active metabolite reduces lymphocyte proliferation and contributes to immunosuppressive activity.
Mycophenolate Mofetil is generally described as a white to off-white crystalline powder. It is practically insoluble in water and has greater solubility in selected organic solvents. Physical characteristics should be controlled according to the applicable API specification.
A controlled Mycophenolate Mofetil API manufacturing process may involve:
Typical Mycophenolate Mofetil API testing may include:
Store Mycophenolate Mofetil API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage conditions should follow validated stability data and the approved API specification.
Mycophenolate Mofetil is relevant to research involving:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 93–94°C |