MetrINo
Published February 10, 2026 | Version v1
Working paper Open

Effect of sampling volume on measurements of size and chemical homogeneity of MRI contrast agent FeraSpin™ R

Authors/Creators

  • 1. EDMO icon University of Pavia
  • 2. UNIVERSITY OF PAVIA
  • 3. ROR icon Physikalisch-Technische Bundesanstalt
  • 4. NanoPET Pharma GmbH, D-10115 Berlin, Germany
  • 5. Laboratoire National de M´etrologie et D'Essais, LNE, DMSI – CARMEN Platform, 29, Avenue Roger Hennequin, 78197 Trappes, France
  • 6. ROR icon Laboratoire National de Métrologie et d'Essais
  • 7. ROR icon Swiss Federal Laboratories for Materials Science and Technology
  • 8. Universitè Paris-Sacly, CEA, CNRS
  • 9. jChemical and Biological Sciences Department, National Physical Laboratory, Hampton road, Teddington
  • 10. Chemical and Biological Sciences Department, National Physical Laboratory, Hampton road, Teddington

Description

Abstract
The use of iron oxide nanoparticles as contrast agents for magnetic resonance imaging (MRI) poses key
questions regarding accurate determination of particle size and chemical composition within microheterogeneous
systems. Here we present the first systematic study on homogeneity for particle size and
chemical composition on the nanoparticle-based MRI contrast agent FeraSpin™ R, combining
complementary analytical tools across a multidisciplinary consortium, clustered around the EURAMET
project MetrINo. Our results indicate that, depending on the target measurand, sizing methods can provide
consistent values for the particle colloidal diameter and for the size of the particle core, independently of
the effective volume of the sample probed. Conversely, the evaluation of homogeneity for chemical
composition depends on the length-scale of the sampling, in agreement with Benedetti–Pichler description
of multicomponent systems. This case study highlights the importance of measurement length-scale for
comparison and integration of data from complementary analytical methods, opening new avenues for
standardization to support regulatory positioning of emerging nanomedicines.

 

Aknowledgments
The project (22HLT04 MetrINo) has received funding from the European Partnership on Metrology, co-financed from the European Union's Horizon Europe Research and Innovation Programme and by the Participating States.
The authors also acknowledge support from the Department of Chemistry of the
University of Pavia and from the Ministero dell'Universit`a e della Ricerca (MUR) through the program “Dipartimenti di
Eccellenza (2023–2027)”. The authors thank Ute Resch-Genger, Elina Andresen, and Carsten Prinz from BAM for useful
discussions. The Cryo-TEM images were obtained at Unitech NOLIMITS, an advanced imaging facility established by the Universit`a degli Studi di Milano. The authors thank Dr Diane Bonnet for technical support and valuable inputs on cryo-TEM.
This work was funded by the European Association of National Metrology Institutes (project number 22HLT04 MetrINo) and by
Ministero dell'Istruzione, dell'Universit`a e della Ricerca, “Dipartimenti di Eccellenza (2023–2027)” HTE Lab Chemistry at University of Pavia. The CEA SAXS platform was supported by a France 2030 grant managed by ANR under the reference ANR22-PEXD-0006 in the frame of the PEPR Diadem initiative.

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Paper Feraspin R_nanoscale advances_final.pdf

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Additional details

Funding

European Association of National Metrology Institutes
MetrINo 22HLT04