OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to ademetionine butanedisulfonate (CAS RN 200393-05-1), adenosylmethionine tosylate bis(sulfate) (S-Adenosyl-L-methionine sulfate tosylate) (CAS RN 97540-22-2), and SAMe-1,4-butanedisulfonate (CAS RN 101020-79-5). Ademetionine, also known as S-Adenosylmethionine (SAMe), is a natural substance present in the cells of the body. It is a direct metabolite of the essential amino acid L-methionine. Ademetionine is used as a drug in many European countries for the treatment of adults with intrahepatic cholestasis in pre-cirrhotic and cirrhotic states, intrahepatic cholestasis in pregnancy and for the treatment of depressive symptoms. It has also been introduced into the United States market as a dietary supplement for the support of bone and joint health, as well as mood and emotional well-being.

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 Ademetionine, just click the ADD TO CART button.

HBEL

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