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Development of a Simultaneous Analytical Method for Amines Corresponding to 10 Typical Nitrosamines.

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Towa Pharmaceutical Co., Ltd., 2-11 Shinbashi-cho, Kadoma, Osaka 571-8580, Japan.

Regulatory authorities in various countries have successively issued notices and guidance to pharmaceutical manufacturers and distributors to evaluate the risk of contamination of nitrosamines in pharmaceutical products and to take appropriate measures. Analysis of nitrosamines in pharmaceutical products is not easy due to the large number of foreign substances, and the risk of contamination is determined by first conducting a desk investigation of the manufacturing process of the APIs or pharmaceutical products. However, a desk investigation may miss the risk since this method is not based on actual measurements.

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