Elemental Impurities Testing

KYMOS provide Elemental Impurities testing for companies seeking assistance to save time and cost before bringing a drug to market. We provide ICP-MS and AAS analysis of Drug Products for human and veterinary use, APIs, excipients, purified water and other sources. Our measurement is carried out using ICP-MS  and AAS instruments, following the ICH Q3D guideline and European Pharmacopoeia and USP General Chapters. 

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Why choose KYMOS for Elemental Impurities Testing

With decades of experience and an optimized operating procedure for elemental impurities testing we can efficiently produce fast and accurate results:

  • Semi-Quantitative Screening: specificity, accuracy (at one concentration level) and detection limits. 
  • Limit Test Validation: specificity, accuracy (at three concentration levels), detection limit or detectability and repeatability, following the European Pharmacopoeia and USP requirements.
  • Quantitative Method Validation: specificity, linearity, accuracy (at three concentration levels), precision (repeatability and intermediate precision), quantification limits and range, following the European Pharmacopoeia and USP requirements.
  • Sample analysis: routine analysis for for quality control or ICH Q3D control strategies.

We can adapt our services to offer specific procedures to suit our clients’ requirements. We also offer Risk Assessment services according to ICH Q3D in collaboration with our regulatory partners.  

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Instrumentation used for Elemental Impurities Testing
Our expert team are solely dedicated to elemental impurities testing. We have an excellent capacity to analyze samples, thanks to our two Ion Coupled Plasma Mass Spectrometers (ICP-MS) Agilent 7700 and Agilent 7800 with high capacity autosamplers. We also have an Atomic Absorption Spectrometer (Varian 240 FS with graphite furnace and hydride generator), which can be used if a specific Pharmacopoeia monograph should be followed. 

Additionally, we also well equipped for sample mineralization and processing by means of an Ultrawave MCLA1000 Milestone. In essence, back-up instruments and a dedicated team ensure tight turnaround at competitive prices. 

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Elemental Impurities KYMOS can test
The European Pharmacopoeia and USP General Chapters are <232>, <233> and <2232> for drug substances, excipients and drug products, will require most drugs, including those for veterinary use, to be tested for the potential presence of  the 24+ elements listed in the ICH Q3D guideline:

Class 1

Class 2A

Class 2B

Class 3

Others

Cd, Pb, As, Hg

Co, V, Ni

Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt

Li, Sb, Ba, Mo, Cu, Sn, Cr

Al, B, Ca, Fe, K, Mg, Mn, Na, W, Zn…

 

Development of new testing standards
Our team continues to implement full testing methods, while developing new assays to comply with new requirements for human and veterinary drugs:
New ICH Q3D-compliant Pharmacopoeia compendial method for Purified Water (04/2018:0008) offering a validated method so clients can directly perform sample analysis saving time and resources.

  • 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 fluids and tissues from preclinical and clinical studies of innovative drugs.
  • Bioequivalence studies of metallic and organometallic compounds containing strontium, lithium, platinum, iron, etc.

 

Discover Elemental Impurities Testing
To find out how KYMOS can help save you time and resources by working in partnership on Elemental Impurities testing, contact us by filling in the form below.

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