OEL Fastrac Catalog

This monograph applies to L-Theanine (CAS RN 3081-61-6) and D-Theanine (CAS RN 5822-62-8). Theanine, an amino acid, is found in tea and certain mushrooms, existing in two primary forms, L-theanine and D-theanine, with L-theanine being the more prevalent variant. The Ltheanine, also known as γ-glutamylethylamide, is mainly present in the tea plant, specifically Camellia sinensis, and is found in only three other species, including one mushroom species and two other members of the Camellia genus. While clinical data is limited, there is some support for the adjunctive use of L-theanine in enhancing specific mood outcomes for patients with schizophrenia and addressing sleep issues in individuals with major depressive disorder, schizophrenia, or generalized anxiety disorder (GAD). Currently, ongoing clinical trials are investigating the effects of L-theanine in boys with attention deficit hyperactivity disorder (ADHD).

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 Theanine, just click the ADD TO CART button.

HBEL

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