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Bosentan impurities form during manufacturing due to various factors, such as impurities in starting materials, intermediates, reagents, and purification steps.
Bosentan impurities are identified and characterized using various analytical methods, such as HPLC and LC-MS. Mass spectrometry can also help determine the molecular weight of impurities.
Yes, impurities in Bosentan can change over time due to storage conditions and exposure to light and heat. It is vital to monitor the quality of Bosentan throughout its shelf life to ensure that it remains safe and effective.
Bosentan 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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