OEL Fastrac Catalog

Reserpine is a naturally occurring alkaloid produced by several members of the genus Rauwolfia, a climbing shrub indigenous to southern and southeast Asia. The compound is used to lower blood pressure and reduce heart rate and as a tranquilizer and sedative. Reserpine also has been used as a tranquilizer and sedative in animal feeds. Reserpine binds tightly to storage vesicles in central and peripheral adrenergic neurons and the drug remains at such sites for prolonged periods of time. The storage vesicles are rendered dysfunctional as a result of their interaction with reserpine, and nerve endings lose their ability to concentrate and store norepinephrine and dopamine. A similar process occurs at storage sites for 5-hydroxytryptamine. Reserpine induced depletion of biogenic amines correlates with evidence of sympathetic dysfunction and antihypertensive effects.

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.

Inquiries on monograph availability

The OEL/ADE monograph for Reserpine is under development.

You can contact us and let us know if you'd like to be notified when this document becomes available.

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