OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to the alternative CAS RN for the base CAS RN 739-71-9 / 3564-66-7, trimipramine maleate (CAS RN 521-78-8 / 138283-60-0/ 138283-61-1/ 1217260-65-5), trimipramine hydrochloride (CAS RN 3589-21-7/ 27855-67-0) and trimipramine mesylate (CAS RN 25332-13-2). Trimipramine maleate is indicated for the symptomatic relief of depression and treatment of depression accompanied by anxiety, agitation or sleep disturbance. Trimipramine maleate is a tricyclic antidepressant. The mode of action of trimipramine maleate capsules on the central nervous system is not known. It is reported to differ from other tricyclic antidepressants and amphetamine-type compounds, as it does not act primarily by stimulation of the central nervous system. Trimipramine does not inhibit neuronal transmitter uptake, and does not cause down-regulation of beta-adrenoceptors. Also, it was found that trimipramine did not antagonize the inhibitory effect of noradrenaline and 5-hydroxytryptamine release, and it does not act by inhibition of the monoamine oxidase system.

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 Trimipramine, just click the ADD TO CART button.

HBEL

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