Elemental Impurities

EAG has extensive experience analyzing elemental impurities in pharmaceutical products. Our dedicated cGMP laboratory features six ICP-MS instruments with multiple microwave digesters. With over 20 years of experience with elemental analysis of drug products, APIs and excipients, EAG scientists know how to help you choose the best route to meet the latest regulations.

Although controlling elemental impurities has always been a critical issue for the pharmaceutical industry, stricter limits and procedures are now defined for heavy metals testing since the implementation of ICH Q3D and the pending implementation of  USP General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements. While the requirements of ICHQ3D and the USP are similar there are key difference which can complicate the study designs.  EAG can help you determine which of the requirements apply to your product and how to navigate these requirements.  The key points and differences between the requirements:

  • Class 1 metals (Cd, Hg, Pb and As) must be risk assessed
  • USP lists 15 target elemental impurities while the ICH references 24
  • Limits for the metals are based on permissible daily exposure (PDE) which varies for each metal based on its toxicity and the route of administration of the final Drug Product.

EAG has developed an ICP-MS method (with microwave digestion) which is capable of monitoring for all of the metals required by both the ICH and USP and a standardized procedure for helping our clients address the regulatory requirements.  The protocol involves:

  • Initial survey screen of the drug product/substance for the full array of metals
  • Method development for specific drug product/substance
  • Method validation for element/product specific procedure
  • Routine samples analysis

ICP-MS (Inductively Coupled Plasma Mass Spectrometry) is the best choice for elemental metals analysis due to its higher sensitivity, specificity and unique ability to monitor all metals simultaneously. EAG has years of experience developing sample preparation methods suitable for pharmaceutical ingredients and products.

EAG Laboratories offers broad experience, extensive capacity and scientific know-how to help your company meet USP requirements for elemental impurities.

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