Which materials should be tested?

While the Elemental Impurities guidelines and chapters generally apply to finished drug products it may be wise to test individual pharmaceutical ingredients such as a starting material, API and/or excipient. This in order to get a detailed view of the individual product and not risking ending up in an OOS situation of a finished product not knowing where a particular set of impurities may originate from.

Which elements should be analyzed?

While arsenic (As), mercury (Hg), cadmium (Cd) and lead (Pb) should always be analyzed due to their natural presence, the testing need will vary between every manufacturer of drug products.

A risk-based approach should be applied when assessing which elements to test for. There are many potential sources of elemental impurities. While the most obvious source would be intentionally added catalysts, trace elements may also originate from sources such as manufacturing equipment, storage containers, raw material, reagents or water, just to name a few.

Analytical results demonstrating compliance with the new regulations should follow a validated method. Screenings or tests that are parts of the risk assessment do not.

How can ALS help?

In collaboration with the client, ALS will set up a tailor made plan for the analytical testing needs of the individual client. This may include:

  • Tailor made screening analysis of up to 70 elements
  • Analytical solutions of all elements included in USP <232>, Ph.Eur. 5.20 and ICH Guidelinies Q3D
  • Testing of elements based on a particular client’s needs
  • Method development and validation services according to ICH Q2 (R1), USP <233>, Ph.Eur 2.4.20 and more.

To see element analysis capabilities at ALS Scandinavia, please read more here.

Elemental impurities testing