Please note, this OEL/ADE monograph also applies to colestipol hydrochloride (CAS RN 37296-80-3). Colestipol is indicated for use in the reduction of cholesterol in the treatment of hyperlipidemias. It is used as an adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia (a condition that features elevated LDL-C) who do not respond adequately to diet. Although colestipol is effective in all types of hypercholesterolemia, it is reported to be most appropriate in patients with Fredrickson's type II hyperlipoproteinemia. It also may be helpful in reducing elevated cholesterol in patients with combined hypercholesterolemia and hypertriglyceridemia; however, it is not formally indicated where hypertriglyceridemia is the abnormality of greatest concern.
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), 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.