The Toxicological Science Division serves to perform nonclinical studies by taking full advantages of a vast array of techniques and renowned reliability that the former Mitsubishi Chemical Safety Institute Ltd. (MSI) had acquired through its broad range of accumulated experience.
Tests on Pharmaceuticals and Agrochemicals
Concentration Analysis of Dosing Formulation, and Characteristic and Stability Study of Test Substance
In safety and safety pharmacology studies performed at the Kashima and Kumamoto Laboratories, precise analysis of the characteristics and stability of test substances applied to GLP studies are demanded under strict standards. Moreover, the concentrations of test substances in dosing formulations actually administrated to animals must be precisely confirmed with the techniques of instrumental analysis etc. In order to fulfill these requirements, we perform analysis studies with HPLC etc. on the basis of highly integrated technology.
Concentration Analysis of Test Substance in Dosing Formulations (Applicable to GLP)
We perform concentration analysis of test substance in dosing formulations required for GLP studies (safety and safety pharmacology studies, etc.) with HPLC, GC, LC-MS/MS and spectrophotometer, etc. All of our analysis methods are validated prior to the analysis tests.
Concentration Analysis of Test Substance in Feed Preparation (Applicable to GLP)
We perform concentration analysis of test substance in feed preparations required for GLP studies (safety and safety pharmacology studies, etc.) with HPLC, GC, LC-MS/MS and spectrophotometer, etc. All of our analysis methods are validated prior to the analysis tests.
Characteristic and Stability Study of Test Substance (Applicable to GLP)
We perform characteristic tests in combination with standard items such as “description”, “IR spectra” and “purity and/or content” to confirm the characteristics and stability of test substances required for GLP studies. All of our quantitative analysis with analytical instrument including HPLC, GC and LC-MS/MS, etc., are validated prior to the analysis.
Examination and Establishment of Analytical Methods
On the basis of the high analytical techniques accumulated and the experience of many test substance analyses in compliance with GLP, smart analytical methods that have both reliability and robustness are efficiently examined and established in a short time. We can develop the most suitable analytical method corresponded to various purposes (analysis of dosing solutions and feed preparations, trace analysis of dosing formulations, and separation analysis of isomer, etc.).
All of our research and studies are in strict adherence to the laws concerning protection and management of animals with full respect of the standards concerning care and management of test animals, and have been accepted and certified for animal welfare practices.
