62574 2025 eng 1 21 article Springer 1 -- -- -- The rational design of engineered nanomaterials (NMs) with improved functionality and their increasing industrial application requires reliable, validated, and ultimately standardized characterization methods for their application-relevant, physicochemical key properties such as size, size distribution, shape, or surface chemistry. This calls for nanoscale (certified) reference materials (CRMs; RMs) and well-characterized reference test materials (RTMs) termed also quality control (QC) samples, assessed, e.g., in interlaboratory comparisons, for the validation and standardization of commonly used characterization methods. Thereby, increasing concerns regarding potential risks of NMs are also addressed and the road for safe and sustainable-by-design concepts for the development of new functional NMs and their use as nanomedicines is paved. With this respect, we will provide an overview of relevant international standardization and regulatory activities, definitions, and recommendations on characterization methods and review currently available organic or inorganic nanoscale CRMs, RMs, and RTMs, including their characterization or certification. In addition, we will highlight typical applications to streamline the regulatory approval process and improve manufacturability including the special challenges imposed by the colloidal nature and sometimes limited stability of NMs. Subsequently, we will critically assess the limitations of currently available nanoscale RMs and RTMs and address the gaps to be filled in the future such as the availability of NMs that come with reference data on properties other than commonly addressed particle size, such as surface chemistry or particle number concentration, or more closely resemble commercially available formulations or address application-relevant matrices. Analytical and Bioanalytical Chemistry 10.1007/s00216-024-05719-6 1618-2650 urn:nbn:de:kobv:b43-625746 publish 20.02.2025 false true Creative Commons - CC BY - Namensnennung 4.0 International Sarah-Luise Abram Isabella Tavernaro Ute Resch-Genger L. J. Johnston S. Zou eng uncontrolled Nano eng uncontrolled Particle eng uncontrolled Silica eng uncontrolled Quality assurance eng uncontrolled Reference material eng uncontrolled Review eng uncontrolled Surface chemistry eng uncontrolled Size eng uncontrolled Shape eng uncontrolled Particle number concentration eng uncontrolled Lipid nanoparticles eng uncontrolled Metal nanoparticles eng uncontrolled Liposomes Analytische Chemie Ingenieurwissenschaften und zugeordnete Tätigkeiten 1 Analytische Chemie; Referenzmaterialien 1.2 Biophotonik Material Chemie und Prozesstechnik Chemische Charakterisierung und Spurenanalytik Verlagsliteratur Datei für die Öffentlichkeit verfügbar ("Open Access") Wissenschaftliche Artikel der BAM Advanced Materials Materialdesign Bundesanstalt für Materialforschung und -prüfung (BAM) https://opus4.kobv.de/opus4-bam/files/62574/Nanosc. ref. and test mat. for the valid. of characteriz. meth. for engineered nanomat.pdf