[Analysis Case] Analysis of Elemental Impurities in Pharmaceuticals (ICH Q3D)

Conducting analysis by finding optimal analysis conditions with reliable analytical techniques! A case where good results were obtained for all items.

We would like to introduce a case of elemental impurity analysis of pharmaceuticals (active ingredients, intermediates, formulations) using ICP/MS under the quality control system required by GMP. In this analysis, since the components differ for each pharmaceutical, selecting the appropriate pretreatment method and choosing the internal standard are key to optimizing the ICP/MS conditions. We conduct the analysis by finding suitable analytical conditions with reliable analytical techniques. We also perform validation tests for each pharmaceutical, simultaneous screening analysis (70 elements from Li to U), and analysis using the ICP/AES method, so please feel free to consult us. 【Validation Plan】 ■ Using commercially available oral formulations, we conduct validation in accordance with USP <233> using microwave digestion-ICP/MS method. ■ Based on the PDE value, we convert the maximum daily intake of the formulation to 10g and calculate the concentration limit value J for the target elements. ■ We set 1/10 of the concentration limit value as the target quantification limit and conduct validation for 9 items. *For more details, please refer to the PDF document or feel free to contact us.

Contract measurement