Nanoscale reference and test materials for the validation of characterization methods for engineered nanomaterials -...

Area of Science:

• Nanomaterial science
• Analytical chemistry
• Materials science

Background:

• Engineered nanomaterials (NMs) require validated characterization methods for industrial applications and safety assessments.
• Standardization of methods for physicochemical properties (size, shape, surface chemistry) is critical.
• Existing concerns about NM risks necessitate reliable quality control (QC) samples.

Purpose of the Study:

• To provide an overview of international standardization and regulatory activities for NM characterization.
• To review available nanoscale reference materials (CRMs, RMs, RTMs) and their characterization.
• To identify limitations and future needs for nanoscale reference materials.

Main Methods:

• Review of international standardization and regulatory frameworks.
• Compilation and assessment of existing organic and inorganic nanoscale CRMs, RMs, and RTMs.
• Analysis of applications, challenges (colloidal nature, stability), and future research gaps.

Main Results:

• Overview of standardization efforts and regulatory landscapes.
• Catalog of currently available nanoscale reference materials with their characterization data.
• Identification of limitations in current reference materials, particularly for surface chemistry and particle number concentration.

Conclusions:

• Validated characterization methods and standardized reference materials are essential for the safe and sustainable development of functional NMs and nanomedicines.
• Further development of nanoscale reference materials is needed to cover a broader range of properties and application-relevant matrices.
• Addressing current gaps will streamline regulatory approval and improve NM manufacturability.