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[Technology and Achievements] High-Sensitivity Analytical Techniques Supporting Impurity Management

Introducing the high-sensitivity analysis technology matrix! We possess high-sensitivity analysis technology that guarantees the high quality of active pharmaceutical ingredients.

In recent years, regulatory authorities have focused on impurities remaining in active pharmaceutical ingredients and have demanded strict management of these by pharmaceutical companies. In particular, the management values for potential mutagenic substances (PMIs) are often in ppm units, but SpiraPharma possesses high-sensitivity analytical techniques tailored to the characteristics of PMIs, enabling the assurance of high quality in active pharmaceutical ingredients. To date, we have established over 300 analytical methods that guarantee PMI residues below 10 ppm. [Features] ■ MS: High selectivity and specificity ■ LC/FID, UV: Wide versatility ■ GC: Good peak shape *For more details, please refer to the PDF document or feel free to contact us.

• Company：スペラファーマ
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