[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.
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Our company is a pharmaceutical CMC research and development contract company that spun out from the CMC research division of Takeda Pharmaceutical Company Limited in July 2017. We support excellent pharmaceutical development as experts in CMC research. Our research team consists of experts with extensive experience and achievements in process chemistry, formulation research and development, and analytical testing development related to CMC research. We provide high-level services and solutions tailored to our customers' needs across each process from the early stages of pharmaceutical development to application, while flexibly collaborating. We have established a collaborative system with partner companies, enabling us to offer a one-stop service. Please utilize us as a platform for your pharmaceutical development.