Elemental Impurities

Elemental impurities can come from many different sources, including the active pharmaceutical ingredient, excipients, and from leaching during the drug’s manufacturing and/or packaging.  Elemental impurities have always been a key issue for pharmaceuticals, but with FDA’s January 1, 2018 implementation of the US Pharmacopeia (USP) General Chapters <232> and <233>, testing is now mandated for all new and existing drugs (learn more).

Why Choose VR Analytical for Your Elemental Impurity Testing

Quality – We undergo annual ICP-MS proficiency testing by a third party (Sigma-Aldrich), with 100% passing results at >96% accuracy in our most recent test.

Advanced Techniques – We use advanced ICP-MS techniques, including the use of three collision gases enabling low-level detection of elements usually obscured by polyatomic interferences (e.g. sulfur and silicon). Detection limits are typically sub parts per billion (ppb) (including elements such as calcium, silicon, sodium, potassium), or even sub parts per trillion (ppt) for some elements and applications.

Challenging Sample Prep – If it is necessary to convert your sample into a form that can be analyzed by ICP-MS, we use closed-vessel microwave digestion, open-vessel block digestion (if elemental volatility is not an issue), acid digestion, and base digestion. The microwave digestion system can digest difficult samples, such as plastics, lubricants, and pharmaceuticals, as the working temperature can reach as high as 220 °C.

Elemental Impurities Quote Request Form

Please use the following form to request a quote for an elemental impurities study:

**Include these targets if USP 661.1/661.2 are relevant (refer to chapter for specific targets per plastic type).