Please note, this OEL/ADE monograph also applies to quizartinib dihydrochloride (CAS RN 1132827-21-4). Quizartinib (AC220), as quizartinib dihydrochloride, is the dihydrochloride salt form of quizartinib, an orally available small molecule with potential antineoplastic activity (2). The proposed indication of quizartinib is the treatment of adults with relapsed or refractory (R/R) acute myeloid leukemia (AML) that is Feline McDonough Sarcoma-like tyrosine kinase (FLT)3-internal tandem duplication (ITD) positive, as detected by an approved test (3). Currently, quizartinib is not approved in the United States or in Europe (4, 5). It is approved in Japan for the treatment of adult patients with relapsed/refractory FTL3-ITD-positive acute myeloid leukemia.
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 Quizartinib, just click the ADD TO CART button.
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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.