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>.
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.
Formulation Excipients
Active Pharmaceutical Ingredients (API)
In-Process Formulations
Finished Products
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
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
Ready to Get Started? Connect with our team to discuss your testing needs.