OEL Fastrac Catalog

Metadoxine is a pyridoxine mixture with pyrrolidonecarboxylic acid (1 to 1 ratio) and has been used in the treatment of alcoholism, alcohol poisoning, and alcohol withdrawal syndrome. It is also under investigation for use in the treatment of attention deficit/hyperactivity disorder (ADHD) and Fragile X syndrome. Metadoxine is an ion-pair salt of pyridoxine (the 4-methanol or des-phosphate form of vitamin B6) and 2-pyrrolidone-5-carboxylate (PCA). Metadoxine exerts its pharmacological effects through the synergistic activity of PCA and pyridoxine. Pyridoxine is a precursor of coenzymes including pyridoxal phosphate, which are necessary for the biosynthesis of four key neurotransmitters (serotonin, epinephrine, norepinephrine, and γ-aminobutyric acid) and for the acceleration of metabolic ethanol degradation. PCA is present in the diet and is produced endogenously; it is linked to the gamma-glutamyl transferase (GT) activity of the liver and reduced levels of glutathione.

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 Metadoxine, just click the ADD TO CART button.

HBEL

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