Benserazide

Please note, this OEL/ADE monograph also applies to benserazide hydrochloride (CAS RN 14919-77-8). Benserazide is a peripheral decarboxylase inhibitor indicated for the treatment of Parkinson’s disease in combination with levodopa. Benserazide, a peripheral decarboxylase inhibitor, blocks the decarboxylation of levodopa, the metabolic precursor of dopamine. Dopamine is depleted in the brain of Parkinson’s patients. Benserazide is hydroxylated to trihydroxybenzylhydrazine in the intestinal mucosa and the liver. It is a potent inhibitor of the aromatic amino acid decarboxylase and protects levodopa from decarboxylation to dopamine in the intestine, before it passes the bloodbrain barrier. Benserazide also inhibits other peripheral enzymes, but is significantly more specific to decarboxylase. Administration of benserazide with levodopa allows levodopa to exert its primary action in the central nervous system (CNS), rather than in peripheral tissue, which can cause adverse effects including nausea, vomiting, and cardiac arrhythmias. No other pharmacodynamic effects of benserazide, other than decarboxylase inhibition, have been reported.

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.

Benserazide

CAS Registry Number:
322-35-0
Trade names:
Prolopa®, Levobens®, Madopar®
Cost:
$639 USD

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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), 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. 10-12 pages in length, with calculations and cited references.
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To order an OEL monograph for this compound, just click the ADD TO CART button.

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  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories