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Elemental Impurities

Life Sciences / Central Laboratory Services / Elemental Impurities

Complete Elemental Testing for Trace Metals & Impurities

Comply with quality control standards by leveraging our analytical services to monitor label-claims and demonstrate control of trace-level elemental impurities. Our team provides full-service GMP laboratory capabilities to assess the levels of elemental impurities in your raw materials, in-process formulations, and finished pharmaceutical or medical device products.

We adhere to guidelines outlined in the European Pharmacopoeia (EP) chapters 5.20 and 2.4.20 and the United States Pharmacopoeia (USP) general chapters USP <232> and USP <233>.

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Elemental Metals Testing

Elemental metals may be formulated into products for functional, therapeutic, or nutritional benefits. In contrast, they may also be natural, process, or contaminant impurities. We have a broad base of experience in testing materials and products for both beneficial minerals and inorganic impurities using a variety of instrumental techniques.

Sample Preparation
  • Low-temperature Digestion Blocks
  • High-temperature Digestion Blocks
  • Microwave Digestion
  • Inductively-coupled Plasma Mass Spectrometry (ICP-MS)
  • Inductively-coupled Plasma Optical Emission Spectroscopy (ICP-OES)
  • Flame-Aspiration Atomic Absorption Spectroscopy (AA)
  • Graphite-Furnace Atomic Absorption Spectroscopy (GFAA)
  • Cold-Vapor Atomic Absorption Spectroscopy (CVAA)
  • Ion Chromatography (IC), Low-level Anions and Cations
Raw Materials & Finished Goods
  • Formulation Excipients
  • Active Pharmaceutical Ingredients (API)
  • In-Process Formulations
  • Finished Products
  • In-house Methods for Screening, USP Class 1 and Class 2 Metals, by ICP-MS
  • Qualitative Screening Methods by ICP-OES
  • Quantitative Assays
  • Custom Method Development & Validation

Integrated Laboratory Services  

When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.

Additional Resources

Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.

Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.

Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.

Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.