Please note, this OEL/ADE monograph also applies to Procaine hydrochloride (CAS RN 51-05-8), Procaine butyrate (CAS RN 136-55-0), Procaine borate (CAS RN 149-13-3), Procaine ascorbate (CAS RN 4846-79-1), Procaine dihydrate (CAS RN 6192-89-8), Procaine nitrate (CAS RN 6192-92-3), Procaine pidolate (CAS RN 17140-49-7), Procaine isobutyrate (CAS RN 17146-93-9), Procaine phosphate (CAS RN 54812-66-7), Hydroxyprocaine (CAS RN 487-53-6), and Oxyprocain hydrochloride (CAS RN 551-36-0). Procaine is a benzoic acid derivative with local anesthetic and antiarrhythmic properties. Procaine is mainly used for infiltration anesthesia, peripheral nerve block, and spinal block. It is also indicated for local anesthetic primarily in oral surgery. Procaine is also used as a part of the complex procaine benzylpenicillin, which is an active constituent of various intramammary and parenteral products in veterinary medicine, as well as in human medicine. Procaine when combined with benzylpenicillin, can prolong the pharmacological effects of benzylpenicillin, reducing the solubility of the latter. This form is an equimolecular mixture of procaine and benzylpenicillin. Procaine benzylpenicillin has the same antimicrobial action as benzylpenicillin but, because of the relatively low blood concentration produced, its use should be restricted to infections caused by microorganisms that are highly sensitive to penicillin.

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.


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$679 USD


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.

How to order

To order an OEL/ADE monograph for Procaine, just click the ADD TO CART button.


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Affygility Solutions’ 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