Benzoic Acid

Please note, this OEL/ADE monograph also applies to Sodium benzoate (CAS RN 532-32-1), Magnesium benzoate (CAS RN 553-70-8), Zinc benzoate (CAS RN 553-72-0), Benzyl alcohol (CAS RN 100-51-6), Potassium benzoate (CAS RN 582-25-2), Ammonium benzoate (CAS RN 1863-63-4), Calcium benzoate (CAS RN 2090-05-3), and Potassium benzoate trihydrate (CAS RN 6100-02-3). Benzonatate is indicated for cough. Suppresses cough through a peripheral action, anesthetizing the stretch or cough receptors of vagal afferent fibers, which are located in the respiratory passages, lungs, and pleura; also, may suppress transmission of the cough reflex by a central mechanism, at the level of the medulla. Benzonatate suppresses cough through a peripheral action, anesthetizing the stretch or cough receptors of vagal afferent fibers, which are located in the respiratory passages, lungs, and pleura. Benzonatate suppress transmission of the cough reflex by a central mechanism, at the level of the medulla in the brain. When applied locally, benzonatate has anesthetic effects by binding within the intracellular portion of voltage-gated sodium channels, decreasing the rate of membrane depolarization and increasing the threshold for electrical excitability. Unlike narcotics, benzonatate has no inhibitory effects on the respiratory center.

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.

Benzoic Acid

CAS Registry Number:
104-31-4
Trade name:
Whitfield’s Ointment®
Brand names:
Tessalon Perles®, Zonatuss®
Cost:
$679 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), 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.
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To order an OEL/ADE monograph for Benzoic Acid, just click the ADD TO CART button.

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  • K. Rosenthal
  • Director of Manufacturing