Sacubitril

Please note, this OEL/ADE monograph also applies to sacubitril sodium (CAS RN 149690-05-1). Sacubitril is used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin II receptor blocker (ARB). Sacubitril acts as a neprilysin inhibitor and valsartan acts as an angiotensin receptor blocker. In combination, they inhibit neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and block the angiotensin II type-1 (AT1) receptor via valsartan. The cardiovascular and renal effects of these drugs in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan.

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, the acceptable surface limit (ASL), and the Permitted Daily Exposure (PDE) value.

Sacubitril

CAS Registry Number:
149709-62-6
Synonyms:
Synonyms, if needed
Trade names:
Trade names, if needed
Brand names:
Brand names, if needed
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), 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

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  • Fully documented. 10-12 pages in length, with calculations and cited references.
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  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories