Duloxetine - NDSRI's

References
FAQ's

Frequently Asked Questions

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.

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.

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.

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.

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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