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Daptomycin
References
FAQ's
References
- Tom E. Eaton, Lynda M. Ford; Otis W. Godfrey, Jr., Mary L. B. Huber; MUton J. Zmijewski, Jr., Eli Lilly and Company, ”Process for producing the A-21978C antibiotics”, US4,800,157, Jan 24, 1989
- Patrick J. Baker, Greenwood; Manuel Debono, Indianapolis; Khadiga Z. Farid, Lebanon; R. Michael Molloy, Eli Lilly, and Company, “Anhydro- And Isomer-A-21978C Cyclic Peptides”, US 5,912,226, June 15, 1999
- Lorena Baietto, Antonio D’Avolio, Francesco Giuseppe De Rosa, Silvia Garazzino, Marianna Michelazzo, Giusi Ventimiglia, Marco Siccardi, Marco Simiele, Mauro Sciandra & Giovanni Di Perri; “Development and validation of a simultaneous extraction procedure for HPLC-MS quantification of daptomycin, amikacin, gentamicin, and rifampicin in human plasma” Analytical and Bioanalytical Chemistry, Volume: 396, Issue: 2, Pages: 791-798, Journal; 2010
Frequently Asked Questions
How are Daptomycin impurities synthesized?
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.
How are Daptomycin impurities detected?
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.
What measures are taken to control Daptomycin impurities?
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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