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EN
EN
Service
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
Classification | Elemental Impurities |
Class 1 | Cd，Pb，As，Hg |
Class 2A | Co，V，Ni |
Class 2B | Ti，Au，Pd，Ir，Os，Rh，Ru，Se，Ag，Pt |
Class 3 | Li，Sb，Ba，Mo，Cu，Sn，Cr |
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
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