Analysis of Nitrosamine Impurities

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asked Apr 18, 2022 in Cell Tracking by HelenS. (1,580 points)

CD Formulation offers testing for nitrosamine impurities, for which the following testing requirements apply.

Manufacturers must be aware of the possible sources of nitrosamine formation during the manufacturing process and take appropriate control measures to reduce the potential for the formation of these carcinogenic impurities. The pharmaceutical industry needs to go beyond superficial phenomena and recognize that the quality of reagents and solvents, especially those used relatively upstream in the manufacturing process, are critical to ensuring the quality of the final drug.



Analysis of Nitrosamine Impurities

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