Ethanol

Ethanol is indicated for use in increased calorie diet and used for other conditions such as methanol and ethylene glycol toxicity. Ethanol is bacteriostatic at low concentrations, but has bactericidal activity at higher concentrations; it does not, however, destroy bacterial spores. In the total absence of water, proteins are not denatured as rapidly as when water is present. Its bactericidal activity drops sharply when diluted below a 50% concentration and the optimal bactericidal concentration is 60 to 90% by volume. Alcohol also has some fungicidal and virucidal activity. It is used to disinfect skin before injection, venepuncture, or surgical procedures. It is also used to disinfect hands and clean surfaces. A concentration of 70%, often as methylated spirits, is commonly used for disinfection.

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.

Ethanol

CAS Registry Number:
64-17-5
Synonyms:
absolute alcohol, alcohol, ethyl alcohol, grain alcohol
Cost:
$597 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.
  • 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 monograph for this compound, just click the ADD TO CART button.

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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories