Please note, this OEL/ADE monograph also applies to alternate CAS RN 18288-22-7, bismuth subnitrate (CAS RN 1304-85-4), bismuth subcitrate potassium (CAS RN 880149-29-1), Bismuth subcitrate (CAS RN 57644-54-9), bismuth subcarbonate (CAS RN 5892-10-4), Bismuth tribromphenate (CAS RN 5175-83-7), bismuth subgallate (CAS RN 99-26-3), bismuth subsalicylate (CAS RN 14882-18-9) Bismuth citrate (CAS RN 813-93-4), Bismuth nitrate pentahydrate (CAS RN 10035-06-0), Bismuth salicylate (CAS RN 5798-98-1; 7460-14-2; 19034-57-2), Bismuth nitrate (CAS RN 10361-44-1), Bismuth trioleate (CAS RN 5128-95-0; 52951-38-9), Bismuth camphocarbonate (CAS RN 19495-28-4), Bismuth acetate (CAS RN 22306-37-2; 29094-03-9), Bismuth phosphate (CAS RN 10049-01-1; 17409-92-6), Bismuth hydrate (CAS RN 10361-43-0), Bismuth sodium tartrate (CAS RN 31586-77-3), Ammonium bismuth citrate (CAS RN 67953-07-5; 25530-63-6; 31886-41-6), Bismuth potassium tartrate (CAS RN 5798-41-4), Bismuth resorcin (CAS RN 1381787-28-5), Bismuth gluconate (CAS RN 94232-39-0), Bismuth orthoborate (CAS RN 14059-35-9), Sodium bismuth tartrate (CAS RN 31586-77-3), and bismuth valproate (CAS RN 94071-09-7). Bismuth subnitrate is indicated for the treatment of Helicobacter-pylori-associated peptic ulcers, duodenal ulcers, painless diarrhea, and as an antacid. It is also used to make enamel fluxes, cosmetics, topical lotions, and ointments.

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.


CAS Registry Number:
Trade names:
Teat-Seal®, Orbeseal®
$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 Bismuth, 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