Elemental Impurity analysis is required for both heavy metals and trace elements in pharmaceutical, nutraceutical,  and allied industries to determine levels of these elemental impurities (if present) are safe for human consumption. Both the FDA and ICH provide recommendations regarding methods for impurity testing and acceptable impurity limits. 

In addition, US Pharmacopeia General Chapters <232> and <233> describe wet chemistry procedures for the analysis of heavy metal elemental impurities in pharmaceuticals. 

Usually, the source of trace metals or elemental impurities include:

• Residual catalyst or inorganic reagents added in synthesis
• Contamination from manufacturing and process equipment
• Impurities added in the preparation of the drug product
• Trace metals absorbed from soil during cultivation/growing of natural health products/supplements (NHPs).
  
  

Adhering to GMP, Shields Pharma Inc.  provides trace metals or elemental impurity analysis using  microwave digestion and Agilent 7800 ICP-MS instrumentation  following USP <232> and <233>, EP (2.4.20), ICH Q3D or as per client method.