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Daptomycin is extracted from the fermentation broth, purified, and then subjected to derivatization reactions to create impurities. The impurities are characterized using analytical techniques. The manufacturing process must adhere to strict regulatory guidelines to ensure the safety and efficacy of the final product.
Daptomycin impurities are detected using analytical techniques such as high-performance liquid chromatography3 (HPLC), liquid chromatography-mass spectrometry (LC-MS), etc. These techniques can identify and quantify impurities in the drug product.
Different measures are taken to control Daptomycin impurities that include optimizing the synthesis and purification process, controlling environmental factors such as temperature and humidity, and monitoring the drug product throughout its shelf life. These measures aim to minimize impurities levels and ensure the drug's quality and safety.
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