OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to barbital sodium (CAS RN 144-02-5). he first of the barbiturates to come onto the market was diethyl-barbituric acid, also known as barbital. Synthesized in 1881 by treating the argentic salt of barbituric acid with ethyl iodide, it was introduced clinically as a hypnotic by the German companies E Merck (Darmstadt) and F Bayer and Co (Elberfeld) in 1904. Barbital and its sodium salt, barbital sodium, are long-acting barbiturates that depress most metabolic processes at high doses. They were used as hypnotics and sedatives and may induce dependence. Barbital is also used in veterinary practice for central nervous system (CNS) depression. Barbital is a schedule IV-controlled drug.

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 Barbital, just click the ADD TO CART button.

HBEL

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