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Elemental Impurities Studies

The laboratory is equipped with Inductively Coupled Plasma Mass Spectrometry (ICP-MS). We can provide elemental impurities study service, including:

◆The strategy of assessment and control of elemental impurities：Assess the elemental impurities in pyroducts according to ICH Q3D and national pharmacopoeia, and provide corresponding control strategies

◆Development and validation of analytical methods for elemental impurities

◆Elemental impurities analysis

◆Elemental classification according to ICH Q3D 

         Elemental Impurities Solution：

◆Elemental impurities scanning: Compare with the blank solution by ICP-MS scanning

◆Methods development

◆Methods validation: Comprehensive validation of analytical methods; Validation protocol and report in Bilingual；Support dual submission in China and United States.

◆Assessment report of elemental impurities