OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to pemetrexed disodium (CAS RN 150399-23-8), pemetrexed disodium heptahydrate (CAS RN 357166-29-1), pemetrexed dipotassium (CAS RN 1438895-00-1), pemetrexed diarginine (CAS RN 1639418-21-5), pemetrexed ditromethamine (CAS RN 1645228-03-0), pemetrexed tromethamine (CAS RN 1851348-04-3), and Pemetrexed sodium hydrate (CAS RN 357166-30-4). Pemetrexed is indicated to treat malignant mesothelioma and non-small cell lung cancer. Pemetrexed is a folate analog metabolic inhibitor that exerts its antineoplastic activity by disrupting folate-dependent metabolic processes essential for cell replication. In vitro studies have shown that pemetrexed inhibits thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), all folatedependent enzymes involved in the de novo biosynthesis of thymidine and purine nucleotides. Preclinical studies have shown that pemetrexed inhibits the in vitro growth of mesothelioma cell lines (MSTO-211H, NCI-H2052).

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.

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. Over 20 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 Pemetrexed, just click the ADD TO CART button.

HBEL

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