OEL Fastrac Catalog

Dexpanthenol is a synthetic alcohol of pantothenic acid (vitamin B5). It used as a food additive, in multivitamins, and in cosmetics. Pantothenic acid occurs naturally in the body. Dexpanthenol is used prophylactically after surgery to prevent atony of the intestine, treat itching skin and minor wounds. Pantothenic acid is purported to have additional beneficial effects including, but not limited to, increased athletic performance, constipation, dry eyes, allergies, and hair loss; although data may not support them all. Dexpanthenol is an alcohol of D-pantothenic and cholinergic agent. It is readily oxidized to pantothenic acid which is in turn a precursor to coenzyme A, a cofactor of a variety of enzyme catalyzed reactions including synthesis of acetylcholine. Dexpanthenol may increase the effect of acetylcholine. It also acts on the gastrointestinal tract and increases gut motility. When applied topically, it relieves itching and promotes health.

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 Dexpanthenol, just click the ADD TO CART button.

HBEL

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