[Column] Management of Potential Mutagenic Impurities

Our company has experience in establishing over 300 analytical methods that can guarantee PMI residues of 10 ppm or less.

In recent years, regulatory authorities have focused on impurities remaining in active pharmaceutical ingredients and formulations, requiring pharmaceutical companies to manage them strictly. At SPERAPHARMA, in managing PMIs, we identify not only the raw materials, reagents, and isolated intermediates used in the manufacturing process but also the expected reaction intermediates (non-isolated intermediates) and various types of related substances within the raw materials and intermediates, aiming to prevent the contamination of these impurities, regardless of their manifest or latent presence. So far, we have established over 300 analytical methods that guarantee PMI residues below 10 ppm, enabling us to meet the increasingly stringent requirements of regulatory authorities. As the difficulty of new drug development increases, we are refining our technologies to reliably contribute to solving challenges related to PMI management, responding to the needs of our customers who are dedicated to the creation of new pharmaceuticals. *For more details on the column, please refer to the related link. For further inquiries, feel free to contact us.*

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