Introduction to High-Sensitivity Analysis Techniques for Elemental Impurities
~ Providing solutions for ICH Q3D

The following are possible routes of elemental impurities. Even in processes that do not use metal catalysts, the possibility of contamination cannot be denied. Risk assessment is conducted, and the elements considered to be at risk need to be evaluated.

Usually, it is difficult to handle antibiotics such as cephems, for which cross-contamination is a concern in analytical laboratories attached to manufacturing sites. However, Shionogi Pharma can handle a wide variety of samples, ranging from general drugs to highly pharmacologically active substances, including antibiotics, and can be measured. Utilizing pharmaceutical companies' experience as analytical laboratories and using microwave decomposition techniques, it is possible to provide solutions that optimize sample preparation methods to match diverse sample matrices and the elements and compounds of interest without limiting the dosage forms to be measured.

In Shionogi Pharma, the elemental impurity test method can be established using ICP-AES and ICP-MS (e.g., setting of test method, analytical method validation, actual measurement). Sensitive quantitative analysis (limit of quantification of less than 1/10 of the acceptable concentration) is used to meet the requirements of ICH Q3D. Analytical laboratories have been inspected by foreign authorities and provide reliable data that can be adapted to Data Integrity applications abroad.