Elemental Impurity Analysis

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Elemental Impurity analysis is the determination of both heavy metals and trace metals in pharmaceutical products. This analysis helps protects patients by ensuring approved products have safe levels of these impurities. Impurities can delay product development or can cause recalls. Both the FDA and ICH provide recommendations regarding methods for impurity testing and acceptable impurity limits. 

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 elemental impurities include:

1. Residual catalyst or inorganic reagents added in synthesis
2. Contamination from manufacturing and process equipment
3. Leaching from container closer systems
4. Impurities added in the preparation of the drug product

ChRi Labs provides elemental impurity analysis to the pharmaceutical and drug-device industries.  Using Good Manufacturing Procedures ChRi Laboratories provides elemental impurity testing by ICP-MS, in compliance with USP <232> and <233>, EP (2.4.20), and ICH Q3D. We use interference removal systems to give you reliable, accurate data for both raw materials and finished pharmaceutical products. We also provide both water-based and organic-based systems. Partner with a lab that demonstrates precision in most challenging matrices. 

The trace metal elements detected include:

•  Aluminum, Antimony, Arsenic, Barium, Beryllium, Boron
• Cadmium, Calcium, Cobalt, Copper, Chromium, Hexavalent Chromium
• Gold, Iron, Lead (Pb), Lithium
• Magnesium, Manganese, Mercury, Molybdenum
• Nickel, Palladium, Potassium, Platinum
• Selenium, Silicon, Silver, Sodium
• Sulfur Content
• Tin, Titanium, Thallium, Vanadium, Zinc
• And other metals and analytes