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Some impurities in Elagolix can affect its bioavailability, which refers to the drug's rate and extent of absorption. Careful control of impurity levels ensures consistent and predictable drug absorption.
Regulatory agencies such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have specific guidelines and requirements for controlling impurities in pharmaceutical products, including Elagolix.
Impurities in Elagolix can potentially impact its therapeutic efficacy by altering the drug's pharmacological activity. Therefore, strict control measures are in place to ensure they are within acceptable limits to maintain the drug's desired therapeutic effect.
Elagolix impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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