We respond to elemental impurity analysis of pharmaceuticals with metal analysis techniques cultivated from years of experience!!
● Experts in metal and material analysis conduct elemental impurity analysis of pharmaceuticals (ICH Q3D) from reliability assurance to GMP compliance. ● We propose screening analysis, leaching tests (E&L tests), and analytical methods tailored to our customers' needs. ● In addition to active pharmaceutical ingredients, intermediates, and formulations, we also accept leaching tests from leaching containers. ICH Q3D guideline risk assessment target elements (Figure 1)
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Lab Features ● GMP (Good Manufacturing Practice) compliant testing room ● Implementation of Laboratory Information Management System (LIMS) ● Total support from experts in metal analysis ● Equipped with ashing devices, microwave digestion systems, and ICP-MS in a clean room (Clean room cleanliness; 100–10,000/ft³)
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■Evaluation Procedure for Metal Elements in Pharmaceuticals 1. Risk Assessment - Selection of Target Elements 2. Selection of Evaluation Method - Calculation of Maximum Allowable Concentration (μg/g) 3. Calculation of Allowable Concentration in Formulation Components and Final Products 4. Quantitative Analysis by ICP-MS ⇒ Evaluation by comparison with Maximum Allowable Concentration
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To solve your technical challenges in a ONE-STOP manner, our team of 1,300 technical specialists will respond quickly and accurately while maintaining strict confidentiality. With bases in six locations nationwide, our experts in various fields utilize the latest analytical testing equipment to meet all your needs. We are confident that we can provide results that will satisfy you, and we would be grateful if you could give us a try.