[Information] Considerations regarding ICH-Q3C in our product MTHP

Regarding "ICH-Q3C: Guidelines for Residual Solvents in Pharmaceuticals," MTHP is considered equivalent to Class 3.

In this document, we present our assessment regarding the classification of our product MTHP in accordance with ICH-Q3C, indicating that it is equivalent to Class 3 (low toxicity). The content is as follows: ■ Overview of the assessment ■ About ICH and ICH-Q3C ■ Tests required for ICH classification and calculation of acceptable values ■ List of solvents for each class *For more details, please refer to the PDF document. If you have any questions, please feel free to contact us.

basic information

【Other Publication Contents】 <Regarding the tests and calculation of acceptable values necessary for ICH classification> - Calculation formula for PDE (Permitted Daily Exposure) - Information on genotoxicity tests and coefficients - Safety test results for genotoxicity and general toxicity - Calculation of PDE and comparison with similar solvents *For more details, please refer to the PDF document. If you have any questions, please feel free to contact us.*