Mycophenolate mofetil

Please note, this OEL/ADE monograph also applies to Mycophenolate hydrochloride (CAS RN 128794-94-5). Mycophenolate mofetil is a 2-morpholinoethyl ester of mycophenolic acid used to prevent organ rejection in patients who have received kidney, heart, and liver transplants. Mycophenolate mofetil is an immunosuppressant. It converts mycophenolic acid (MPA), a selective noncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, a key enzyme in de novo guanosine nucleotide synthesis. Because immune cells, unlike other cells, rely on monophosphate dehydrogenase to proliferate, inhibition of this enzyme reduces the immune reaction and lessens graft rejection. MPA has potent cytostatic effects on lymphocytes and inhibits proliferative responses of T- and Blymphocytes to both mitogenic and allospecific stimulation. MPA also suppresses antibody formation by B-lymphocytes. MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Mycophenolate mofetil

CAS Registry Number:
116680-01-4
Brand name:
Cellcept®
Cost:
$639 USD

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Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. 10-12 pages in length, with calculations and cited references.
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To order an OEL/ADE monograph for Mycophenolate mofetil, just click the ADD TO CART button.

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  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories