OEL Fastrac Catalog

L-tryptophan is an essential amino acid and is indicated for the adjunct treatment of depressive disorders (2, 3). It is given in combination with lithium in bipolar patients with mania or depression (2). L-tryptophan is useful in increasing serotonin (5-HT) production, promoting healthy sleep, managing pain tolerance, and managing weight. Tryptophan is critical for the production of proteins, enzymes, and muscle tissue (4, 5). It is also essential for the production of niacin, and the synthesis of the neurotransmitter serotonin and melatonin. During the catabolism of tryptophan, the first key intermediate is kynurenine, which undergoes deamination yielding kynurenic acid. Kynurenic acid and metabolites have been shown to have anti-excitotoxic and anticonvulsive effects.

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 Tryptophan, just click the ADD TO CART button.

HBEL

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