Please note, this OEL/ADE monograph also applies to gonadorelin (CAS RN 33515-09-2), gonadorelin acetate CAS RN 52699-48-6), and gonadorelin hydrochloride (CAS RN 51952-41-1). Salmon gonadotropin-releasing hormone analog (sGnRHa) is used for intraperitoneal (IP) or intramuscular (IM) use as a spawning aid in ornamental finfish broodstock only. Release of stored pituitary gonadotropins may aid spawning by stimulating ovulation and spermiation in sexually mature fish. Salmon gonadotropin-releasing hormone analog (sGnRHa) is legally marketed as an unapproved new animal drug for minor species. This product is indexed but not approved by the Food and Drug Administration (FDA).
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:
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Affygility Solutions’s 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.