Note, this monograph also applies to treprostinil diethanolamine (CAS RN 830354-48-8) and treprostinil sodium (CAS RN 289480-64-4). Treprostinil is a synthetic analog of prostacyclin. It is indicated for use as a continuous subcutaneous (SC) infusion or intravenous (IV) infusion (for those not able to tolerate an SC infusion) for the treatment of pulmonary arterial hypertension (PAH) World Health Organization (WHO) Group 1 in patients with New York Heart Association (NYHA) Class II to IV symptoms to diminish symptoms associated with exercise. Treprostinil is also indicated orally and by inhalation to delay disease progression and to improve exercise capacity.
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 Treprostinil, 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.