ELEMENTAL IMPURITIES

ELEMENTAL IMPURITIES

Kymos has an experienced team dedicated solely to elemental impurities and equipped with two Ion Coupled Plasma Mass Spectrometers (ICP-MS) Agilent (7700, 7800) with high capacity autosamplers and Atomic Absorption (Varian 240 FS with graphite furnace and hydride generator) as well as two Ultrawave digestion systems from Milestone.

The European Pharmacopoeia and USP General Chapters are <232>, <233> and <2232> for drug substances, excipients and drug products, requires most drugs, including those for veterinary use, to be tested for the potential presence of the 24 elemental impurities listed in the ICH Q3D guideline. The chart below comprises all of them plus others required case by case:

Class 1Class 2AClass 2BClass 3Others
Cd, Pb, As, HgCo, V, NiTl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, PtLi, Sb, Ba, Mo, Cu, Sn, CrAl, B, Ca, Fe, K, Mg, Mn, Na, W, Zn…


The guideline is subject to constant revision and updating and our experienced elemental impurities team is constantly keeping up to date. The latest amendments are:

• Addition of Appendix 5: Limits for Elemental Impurities by the Cutaneous and Transcutaneous Route
• Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products

It is not only pharmaceutical guidelines that give our elemental impurities team the right direction. The determination of elemental impurities is also becoming increasingly important in the cosmetics sector. Here it is important to comply with:
• ISO 21392:2021: Cosmetics — Analytical methods — Measurement of traces of heavy metals in cosmetic finished products using ICP/MS technique

Moreover, our elemental impurities team continues to develop additional assays to comply with new regulatory requirements:

• ICH Q3D-compliant pharmacopoeia compendial method for purified water (04/2018:0008)
• In-house validation of ICP-MS determination methods to replace colorimetric compendial methods such as Arsenic monograph (04/2018:20402)
• Bioanalysis of metals in biological samples from preclinical and clinical studies of IMPs
• Bioequivalence studies of metallic and organometallic compounds containing Sr, Li, Pt, Fe

Elemental Impurity lab
elemental and other impuritiesUltrawave MCLA1000 Mileston

Related Services

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Batch Testing and Batch Release

KYMOS and PHARMAPROGRESS are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Stability Studies

Full ICH studies and on-going stability programmes at different storage conditions.

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