Inclisiran

Inclisiran is a synthetic, chemically modified, double-stranded small interfering ribonucleic acid (siRNA) directed against proprotein convertase subtilisin-kexin type 9 (PCSK9). The sense strand contains 21 nucleotides, and the antisense strand contains 23 nucleotides. The sense strand is conjugated with triantennary N-acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. Inclisiran (CAS number 1639324-58-5) has a molecular weight of 16339.51 g/mol and its salt form, inclisiran sodium (CAS number 1639324-62-1) has a molecular weight of 17284.72 g/mol. Inclisiran is a PCSK9 targeted short interfering RNA that lowers plasma low-density lipoprotein cholesterol (LDL-C) levels. It is indicated for treatment in adults with primary hypercholesterolemia (including heterozygous familial and nonfamilial) or mixed dyslipidemia, as an adjunct to diet either in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

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.

Inclisiran

CAS Registry Number:
1639324-58-5
Trade name:
Leqvio®
Cost:
$679 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.

How to order

To order an OEL/ADE monograph for Inclisiran, 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