For API's, excipients, raw materials or drug products, for stability studies, for investigations or quality control, Antellis proposes :

  • Screening of the 24 elemental impurities : Class 1 (As, Cd, Hg, Pb), Class 2A (Co, Ni, V), Classe 2B (Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, Tl), Class 3 (Ba, Cr, Cu, Li, Mo, Sb, Sn)) for ICH Q3D risk analysis.
  • Method verification (24 elemental impurities, class 1, 2A, 2B, 3) for ICH Q3D risk analysis.
  • Semiquantitative screening of the periodic classification of elements (screening of 50 elements).
  • Characterisation and quantitation of mineral impurities.
  • Development and validations of methods according to the following guidelines : ICH Q2(R1), Ph.  Eur. 2.4.20, 2.2.57, 2.2.58, USP <233>, <730> with method validation plans and final reports.

Some examples of performed analyses :

  • Validation of ICP-MS method and quantitation in API’s and drug products : Pt, Ni, Fe, Pd, Na, B, V, Ti,…
  • Determination of elemental impurities : heavy metals, catalysts, phamacopeias metals : As, Cd, Pb, Hg, Al, Mo, V, Ag, Pt, Ru, Ni, Pd, Rh,…

Heavy metal determination in cosmetic industry is becoming a major problem with the definition and the further application of new rules.

Antellis is providing to cosmetic industry his knowledge of geologic and mineral matrices used as pigments or filters.

For raw material sourcing or quality control of semi-finished or finished products, antellis proposes :

  • Semiquantitative screening of 50 elements.
  • Identification and quantitation of heavy metals, rare earth elements, corrosion.
  • Development and validation of methods according to ISO or pharmacopeias.

Some examples of carried-out analyses :

  • Quantitation of sun filters (TiO2, ZnO) on finished products (fundation creams, sunscreens).
  • Quantitation of heavy metals (As, Cd, Pb, Hg, Ni, Sb, Co, Cr, Sn, Zn) and rare earth elements (La, Ce, Pr, Nd, Eu) in raw materials and pigments (ochres, micas,..).
  • Quantitation of As, Cd, Pb, Hg, Ni, Sb, Co, Cr, Sn, Zn, Al, Fe in lipsticks, foundation cream, creams, lotions, eau de toilette.

In dietary supplements and nutraceuticals industry rules impose very low concentration of heavy metals particularly As, Cd, Pb and Hg. Furthermore antellis is able to control trace elements either added or naturally occuring in raw materials. So, in these matrices and products, Antellis can perform:

  • Elemental impurities quantitation.
  • Oligo elements quantitation.
  • Development and method validation according to ISO or ICH guidelines.

Some examples of performed analyses :

  • Quantitation of elemental impurities (As, Cd, Pb, Hg) in dietary supplements.
  • Quantitation of oligo elements I, Se, Cu, Ca, Mg… in dietary supplements.
  • Quantitation of Se, I, Cu, Ca, Mg, Na, K, P, As, Cd, Hg, Pb in yeast samples, plant extracts, algaes, spirulin.
tubes sang

Antellis develops and validates ICP-MS methods for quantifying elements (Metal based drugs, metallic nanoparticles, medical devices,…) for toxicokinetic studies, pharmacokinetic studies,  ADME, biodistributions, transcutaneous passage studies.

  • Development and validation of bioanalytical methods according to FDA or EMA guidelines.
  • Study/phase plans, critical inspections, final reports.
  • Human and animal matrices : blood, plasma, urine, faeces, tissues, organs, skin, cells.
  • More than 100 studies carried out.

Some examples of carried out analyses :

  • Platinum (Pt) determination in mouse blood and tissues (+ method validations).
  • Hafnium (Hf) determination in rat blood and tissues and in human blood and urine (+ method validations).
  • Calcium (Ca) determination in pericardial membrane.
tube bleu

Antellis determines heavy metal concentrations in raw materials, solvents, finished or semi-finished products according to your specifications. Furthermore, our great reactivity allows us to help manufacturers in investigating incidents during industrial processes (presence of elemental impurities or particles) by quickly realising:

  • Semiquantitative screenings (50 elements).
  • Characterisation and quantitation of mineral impurities, catalysts, corrosion.

Some examples of performed analyses :

  • Quantitation of As, Cd, Pb, Hg, Co, Cr, Cu, Mn, Ni, Ba, Fe, Mg,…in organic solvents, ionic solvents, polymers,….
  • Quantitation of As, Cd, Pb, Hg, Ni, Sb, Se, Zn, Mn,… in minerals (ZnO, MnO2, CuSO4, TiO2,…).
  • Characterisation of corrosion issues (Fe, Ni, Cr, Mo, Mn,..) in raw materials and finished or semi-finish.