OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to phendimetrazine tartrate, bitartrate (CAS RN 50-58-8).Phendimetrazine functions as a prodrug to phenmetrazine, and approximately 30% of any given oral dose is converted into it. Phendimetrazine can essentially be thought of as an extended release and less abusable version of phenmetrazine. Phenmetrazine (and therefore phendimetrazine as well) acts as a norepinephrine-dopamine releasing agent (NDRA). Its structure incorporates the backbone of methamphetamine, a potent CNS stimulant. Whilst adding an N-methyl group to the structure of amphetamine significantly increases its potency and bioavailability, in the case of phendimetrazine the added methyl group results in the compound becoming virtually inactive, at least until the methyl group is removed by the body's metabolism. This results in a steady, continued activation of the drug in the body, both lowering abuse potential and allowing for once-daily administration.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API).

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 monograph for Phendimetrazine, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.