Please note, this OEL/ADE monograph also applies to calcipotriene monohydrate (CAS RN 147657-22-5). Calaspargase pegol is a drug substance produced by Escherichia coli. It is comprised of an E. coli L-asparaginase homotetramer and 31 to 39 molecules of monomethoxypolyethylene glycol (mPEG) with a succinimidyl carbonate (SC) linker. Potency is based on enzyme kinetics. Calaspargase pegol is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years.
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 Calaspargase Pegol, 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.