Dipyrone

Please note, this OEL/ADE monograph also applies to dipyrone sodium (CAS RN 68-89-3) and dipyrone sodium monohydrate (CAS RN 5907-38-0). Dipyrone, also known as metamizole, is a pyrazole that is antipyrine substituted at C-4 by a methyl(sulfomethyl)amino group. The sodium salt, dipyrone sodium, was widely used as a powerful analgesic and antipyretic, but it was withdrawn from many markets beginning in the 1970s due to a risk of causing agranulocytosis. It has a role as an antipyretic, an antirheumatic drug, a nonnarcotic analgesic, a nonsteroidal anti-inflammatory drug (NSAID), a peripheral nervous system drug, a prodrug and a cyclooxygenase (COX)-3 inhibitor (2). Approvals of the new drug application (NDA)'s for dipyrone drug products were withdrawn on June 27, 1977 and the product was withdrawn from the Canadian market in 1963.

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.

Dipyrone

CAS Registry Number:
50567-35-6
Trade names:
Adepiron®, Analgesin®, Baralgin®, Novalgin®
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), 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. 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.

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To order an OEL/ADE monograph for Dipyrone, 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