Givosiran is a small interfering ribonucleic acid (siRNA) directed towards 5-aminolevulinic acid synthase, a critical enzyme in the heme biosynthesis pathway. It consists of a double-stranded, synthetic, chemically modified siRNA and contains a combination -methyl nucleotides conjugated to a triantennary N-acetylgalactosamine (GalNAc) ligand to facilitate delivery of the siRNA to the liver. The two single strands that form the double-stranded RNA molecule are A-122230, the sense strand, and A122227, the antisense strand. The abbreviated chemical name for the sense strand is 5ʹ Cm-ps-Am-ps-GmAm-Am-Am-Gf-Am-Gf-Um-Gf-Um-Cf-Um-Cf-Am-Um-Cm-Um-Um-Am-L96 3ʹ, which is base-paired with the antisense strand 5ʹ Um-ps-Af-ps-Af-Gf-Am-Uf-Gm-Af-Gm-Af-Cm-Af-Cm-Uf-Cm-Uf-Um-Uf-Cm-Uf-Gm-ps-Gmps-Um-3ʹ
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.
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:
To order an OEL/ADE monograph for Givosiran, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
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.