Elemental Impurity Testing

Elemental impurities in drugs have always been an important part of drug quality control and assurance (QC / QA). Some elemental impurities (especially heavy metal elements) will not only adversely affect the stability and shelf life of drugs, but also have potential toxicity and easily cause human diseases. Therefore, in recent years, the international control of elemental impurities in drugs has become more and more strict. Europe and the United States have long put forward clear requirements for elemental impurities in pharmacopoeia and guidelines, and ICH Q3D has also put forward new requirements for the classification and control of elemental impurities.

The elemental impurity testing is an important part of drug quality control and assurance. Good testing can help you identify potential elemental impurities, perform risk assessments, analyze the daily permissible exposure of elemental impurities, and provide technical support to ensure the quality and safety of pharmaceutical products.

STEMart provides high-quality elemental impurity testing services to identify potential elemental impurities in pharmaceutical products, perform risk assessment, and provide technical support to ensure the quality and safety of pharmaceutical products.

Test Samples

Raw material drug, auxiliary materials, finished drug, biopharmaceuticals (pharmaceutical products containing purified proteins and peptides), etc.

Analyzable Element Types

Cadmium, mercury, lead, arsenic, cobalt, vanadium, nickel, aluminum, lithium, chromium, etc.

Service Items

• Identify potential elemental impurities
• Risk assessment of elemental impurities
• Analyze the daily permissible exposure of elemental impurities
• Calculate elemental impurity limits

For more information about our elemental impurity testing services, please contact us.