Abstract

A stable dosage form of Duloxetine in the form of Delayed Release Pellets which has N Nitroso Duloxetine (DLNA) within the AI limits. Control of Nitrosamine compounds with inclusion of nitrite scavengers also called stabilizers in the composition, modifying the manufacturing process or by choosing alternative manufacturing technologies.

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This work is licensed under a Creative Commons Attribution 4.0 License.

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