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Note: this service is for Research Use Only and Not intended for clinical use.
In the pharmaceutical production process, there are a wide range of potential sources of elemental impurities, which may be residues of intentionally added elements (catalysts) in the production process, or may be unintentional addition resulting in the potential presence or introduction of the drug substance and excipients used in pharmaceutical. Therefore, the potential contribution of each source of elemental impurities in the risk assessment process needs to be considered to determine the overall contribution of elemental impurities to the drug. ICH Q3D classifies elemental impurities into four categories based on risk assessment:
Figure 1. Sources of elemental impurities in pharmaceutical
Alfa Chemistry's experts are dedicated to the development and validation of methodologies for the detection of elemental impurities to ensure that your products comply with relevant regulations. As your trusted partner, our experimental team is constantly learning the latest regulations, providing you with the expertise and experience to support all your elemental impurity analysis requirements. If you have any questions about elemental impurity analysis, please feel free to contact us.
Alfa Chemistry's capabilities include but not limited to:
Identify the elements that need to be verified.
Choose the most appropriate pre-processing method.
Meet the testing requirements of EP, USP, ICH Q3D and other regulations.
Qualitative and quantitative analysis of elemental impurities.
Reliable risk assessment.
Alfa Chemistry's technologies for impurities analysis include but not limited to:
Inductively-Coupled Plasma Mass Spectrometry (ICP-MS)