Please note, this OEL/ADE monograph also applies to sodium phosphate monobasic, monohydrate (CAS RN 10049-21-5), sodium phosphate monobasic (CAS RN 7558-80-7), sodium phosphate (CAS RN 7632-05-5), sodium phosphate dibasic, dodecahydrate (CAS RN 10039-32-4), and dibasic sodium phohsphate dihydrate (CAS RN 10028-24-7). Sodium phosphate monobasic dihydrate, the dihydrate of sodium phosphate monobasic, is indicated for use as a laxative in the treatment of constipation or to clean the bowel before a colonoscopy. Phosphates have also been used in the treatment of hypophosphatemia, to lower urinary pH, and for prophylaxis of calcium renal calculi.
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.