[CPhI Seminar Report] Mutagenic Impurities in Pharmaceuticals (Active Pharmaceutical Ingredients)
Development of testing methods and analysis examples! Established over 300 analytical methods that can guarantee PMI residues below 10 ppm!
At "CPhI Japan 2022," we held a presentation in our booth regarding ICH M7 compliance from the Development and Analytical Research Headquarters. We introduced the day's content, including "About ICH M7," "For the Development of Trace Analysis Methods," and "Examples of Method Validation." Please take a moment to read it. [Contents] ■ About ICH M7 ■ For the Development of Trace Analysis Methods ■ Examples of Method Validation ■ Conclusion *For more details, please refer to the related links page 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.
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