Methotrexate

Please note, this OEL/ADE monograph also applies to methotrexate disodium salt (CAS RN 7413-34-5) and methotrexate sodium (CAS RN 15475-56-6). Methotrexate is indicated for the treatment of acute lymphoid leukemia, breast cancer, head and neck cancer, juvenile arthritis, lung cancer, lymphoma, bone cancer, psoriasis, and rheumatoid arthritis. Methotrexate is an antimetabolite that interferes with DNA synthesis, repair, and cellular replication by inhibiting dihydrofolate reductase. Tissues with high rates of cellular proliferation such as neoplasms, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are generally more sensitive to the effects of methotrexate than most normal tissues.

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.

Methotrexate

CAS Registry Number:
59-05-2
Synonyms:
Amethopterin, MTX
Brand names:
Rheumatrex Dose Pack®, Metoject®, Nordimet®, Otrexup®, Rasuvo®
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), as well as PIC/S and ANVISA requirements, 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.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Methotrexate, just click the ADD TO CART button.

HBEL

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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.

Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories