Tivanisiran (formerly known as SYL1001) drug substance is a small interfering oligonucleotide of ribonucleic acid (RNA) (siRNA) designed to silence the human transient receptor potential vanilloid 1 (TRPV1). More specifically is a synthetic, 19-base pair double-stranded ribonucleic acid (RNA) oligonucleotide duplex formed by the hybridization of two complementary single strands of RNA, developed by Sylentis. Hybridization occurs across 19 ribose base pairs to yield the SYL1001 molecule. Tivanisiran is formulated as a completely nonmodified, naked siRNA molecule. It has neither base substitutions, backbone replacements, nor a delivery system. Tivanisiran consists of the sequence sense 5′-AAGCGCAUCUUCUACUUCA-3′ and antisense 3′-UGAAGUAGAAGAUGCGCUU-5.
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 Tivanisiran, 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.