OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Ergoloid mesylates/Dihydroergotoxine mesylate (CAS RN 8067-24-1). Dihydroergotoxine is a mixture of three different hydrogenated derivatives of ergotamine. These are dihydroergocristine (CAS 17479-19-5), dihydroergocornine (CAS 25447-65-8), and dihydroergocryptine (CAS 25447-66-9). Dihydroergotoxine has been proposed to be a neuroprotective agent and a nootropic agent. The methanesulfonate salts of this mixture of alkaloids are called ergoloid mesylates. Ergoloid mesylates are also known as dihydroergotoxine mesylate or codergocrine mesylate. Dihydroergocryptine mesylate exists as a mixture of alpha (α) and beta (β)-isomers. Ergoloid mesylate is a nootropic used as adjunct in the symptomatic treatment in individuals over sixty years of age who manifest signs and symptoms of an idiopathic decline in mental capacity and mild/moderate dementia. It is also prescribed for cognition enhancement in well persons of all ages and for the treatment of cerebrovascular insufficiency.

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 Dihydroergotoxine/Ergoloid Mesylates, just click the ADD TO CART button.

HBEL

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