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.
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:
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