Please note, this OEL/ADE monograph also applies to amiloride hydrochloride anhydrous (CAS RN 2016-88-8) and amiloride hydrochloride dihydrate (CAS RN 17440-83-4). Amiloride is a member of the class of pyrazines resulting from the formal monoacylation of guanidine with the carboxy group of 3,5-diamino-6-chloropyrazine-2-carboxylic acid. It has a role as a sodium channel blocker and a diuretic. It is a member of the pyrazines, an organochlorine compound, an aromatic amine, and a member of the guanidines. Amiloride is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic diuretic agents in congestive heart failure or hypertension to help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic and to prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop (such as patients taking digitalis or patients with significant cardiac arrhythmias). Amiloride is also indicated in the maintenance therapy of patients with hepatic cirrhosis with ascites and edema. In these patients, satisfactory diuresis with diminished potassium loss and decreased risk of metabolic alkalosis may be attained with use of amiloride hydrochloride alone.

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:
Brand names:
Midamor®, Moduretic®, Arumil®, Modamide®
$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.

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


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  • K. Rosenthal
  • Director of Manufacturing