Elemental Impurities analysis

Elemental Impurities analysis

The Elemental Impurities guidelines now being finalized by the United States Pharmacopoeia (USP) and International Council for Harmonization (ICH) presents limits and procedures for the elemental impurities analysis in pharmaceutical, drug products and ingredients such as an API, catalyst, excipient, raw material or reagent.

ALS offers GMP testing services for metal screenings for:

  • GMP batch release
  • Quality control
  • Stability testing
  • API analysis
  • Excipient analysis
  • Metal catalysts
  • And more

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. For more guidelines please read more under the section testing strategy.

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