Duloxetine - NDSRI's
References
FAQ's
References
- Deeter, Jack; Frazier, Jeff; Staten, Gilbert; Staszak, Mike; Weigel, Leland, Asymmetric synthesis and absolute stereochemistry of LY248686, Tetrahedron Letters, Volume: 31, Issue: 49, Pages: 7101-4, 1990
- Johnson, Jason T.; Oldham, Samuel W.; Lantz, Ronald J.; DeLong, Allyn F., High performance liquid chromatographic method for the determination of Duloxetine and desmethyl duloxetine in human plasma, Journal of Liquid Chromatography & Related Technologies, Volume: 19, Issue: 10, Pages: 1631-1641, 1996
Frequently Asked Questions
Why is the analysis of Duloxetine impurities vital?
Analysis of Duloxetine impurities is vital to ensure the medication's quality, safety, and efficacy. It helps identify and quantify impurities to ensure compliance with regulatory requirements and to assess the potential impact on patient health.
Are there specific guidelines for the control of impurities in Duloxetine?
Regulatory authorities, such as the FDA and ICH, provide guidelines and recommendations for controlling impurities in pharmaceutical products, including Duloxetine. These guidelines outline acceptable limits and requirements for impurity profiling and reporting.
How are Duloxetine impurities identified and characterized?
Duloxetine impurities are identified and characterized using advanced analytical techniques such as HPLC, LC-MS, and other spectroscopic methods. These techniques help in determining the chemical structure and properties of impurities.
What temperature conditions are necessary for storing Duloxetine impurities?
Duloxetine impurities are at a controlled room temperature, specifically within 2-8 °C, or as indicated on the Certificate of Analysis (CoA) to ensure proper storage.
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