Please note, this OEL/ADE monographs also applies to alternate CAS RN 2180-92-9, bupivacaine hydrochloride monohydrate (CAS RN 73360-54-0), bupivacaine, D(+)- (CAS RN 27262-45-9), and (+)-Bupicaine hydrochloride (CAS RN 27262-46-0). Bupivacaine is an amide-type, long-acting local anesthetic. It is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. Dextrobupivacaine hydrochloride (anhydrous) is the monohydrochloride salt of dextrobupivacaine. It contains a dextrobupivacaine. It is an enantiomer of levobupivacaine hydrochloride (anhydrous).
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 Bupivacaine, 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.