Mycophenolic Acid API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Mycophenolic Acid API

Mycophenolic Acid (MPA) is a naturally occurring immunosuppressive compound and the active metabolite of mycophenolate mofetil and mycophenolate sodium. It is a selective inhibitor of inosine monophosphate dehydrogenase (IMPDH) and suppresses the proliferation of T and B lymphocytes by reducing de novo guanosine nucleotide synthesis.

Mycophenolic Acid is particularly important in pharmaceutical applications involving immunosuppression and organ transplantation. It is used as the pharmacologically active moiety associated with mycophenolate-based medicines.

The compound has the molecular formula C₁₇H₂₀O₆, molecular weight 320.34 g/mol, and CAS Number 24280-93-1.

About Mycophenolic Acid

Mycophenolic Acid is a fungal-derived immunosuppressive agent originally isolated from Penicillium species. Its pharmacological activity results primarily from inhibition of IMPDH, an enzyme required for guanine nucleotide synthesis.

Because activated lymphocytes depend heavily on the de novo pathway for purine synthesis, inhibition of IMPDH results in reduced proliferation of T and B cells.

Key Features

  • Active pharmaceutical ingredient
  • Immunosuppressive compound
  • Selective IMPDH inhibitor
  • Antimetabolite
  • Used in transplantation-related pharmaceutical applications
  • Also known as MPA
  • CAS Number: 24280-93-1
  • Molecular Formula: C₁₇H₂₀O₆
  • Molecular Weight: 320.34 g/mol
  • Active metabolite of mycophenolate mofetil
  • Active metabolite of mycophenolate sodium
  • Suitable for pharmaceutical research and manufacturing applications

PHARMACEUTICAL APPLICATIONS

Mycophenolic Acid is primarily associated with immunosuppressive therapy, particularly in organ-transplantation medicine.

It is the pharmacologically active metabolite responsible for the immunosuppressive activity of mycophenolate-based pharmaceutical products.

Major Pharmaceutical Applications

  • Organ transplantation
  • Immunosuppressive therapy
  • Kidney transplantation
  • Heart transplantation
  • Liver transplantation
  • Pharmaceutical research involving immune-mediated disorders

Important: On an API page, it is preferable to describe Mycophenolic Acid as an immunosuppressive pharmaceutical ingredient/active metabolite rather than claiming that the standalone API is universally marketed as a finished medicine.

MECHANISM OF ACTION

Mycophenolic Acid acts primarily by inhibiting inosine monophosphate dehydrogenase (IMPDH).

IMPDH plays an important role in the de novo synthesis of guanine nucleotides. Inhibition of this pathway reduces the availability of guanosine nucleotides required for DNA and RNA synthesis.

Activated T and B lymphocytes are particularly dependent on this pathway for proliferation. Therefore, inhibition of IMPDH by Mycophenolic Acid suppresses lymphocyte proliferation and contributes to its immunosuppressive effect.

Detailed Specifications

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%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
Melting Point 141–142°C
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