Evidence map›Paper›PMID 40055198›Full record

ArticleAnalytical and bioanalytical chemistry2025

SI-traceable characterisation of the first reference material for nanoparticle number concentration in suspension to support regulatory compliance.

Dorota Bartczak, Susana Cuello Nuñez, Ada Kubicka, David Ojeda, Armando Sanchez Cachero, Simon Cowen, Stephen Ellison, Gill Holcombe, Heidi Goenaga-Infante

Erratum issuedAbstract read
In one paragraph

Article in Analytical and bioanalytical chemistry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Dorota BartczakNational Measurement Laboratory, LGC Limited, Queens Road, Teddington, UK.
Susana Cuello NuñezNational Measurement Laboratory, LGC Limited, Queens Road, Teddington, UK.
Ada KubickaNational Measurement Laboratory, LGC Limited, Queens Road, Teddington, UK.
David OjedaNational Measurement Laboratory, LGC Limited, Queens Road, Teddington, UK.
Armando Sanchez CacheroNational Measurement Laboratory, LGC Limited, Queens Road, Teddington, UK.
Simon CowenNational Measurement Laboratory, LGC Limited, Queens Road, Teddington, UK.
Stephen EllisonNational Measurement Laboratory, LGC Limited, Queens Road, Teddington, UK.
Gill HolcombeNational Measurement Laboratory, LGC Limited, Queens Road, Teddington, UK.
Heidi Goenaga-InfanteNational Measurement Laboratory, LGC Limited, Queens Road, Teddington, UK. Heidi.Goenaga-Infante@lgcgroup.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Reference materials (RMs) are increasingly needed to support number-based characterisation of nanomaterials (NM) in a regulatory context for the purpose of method development, validation and measurement quality control. To date, RMs for number concentration in suspension with a directly assigned value that is SI traceable have been rather scarce, being the LGCQC5050 the only material commercialised so far. This could be attributed to the limited availability of metrologically validated measurement methods and stability challenges associated with long-term storage of NM suspensions. This paper describes development and characterisation of the first RM consisting of 30-nm colloidal gold nanoparticles and value assigned for particle number concentration using the dynamic mass flow (DMF) method with single particle ICP-MS (spICP-MS). Special attention is paid to systematic assessment of the DMF method's performance under operating conditions set outside recommendations described in ISO/TS 19590:2024, but that still comply with key requirements of this method (e.g. use of an ICP-MS system in equilibrium, a cooled spray chamber, etc.). The results of such investigations are reported here for the first time. The paper also discusses practical considerations for the production, storage and transport of nano RMs, and provides guidance on best practice for the production and certification of future nano RMs in accordance with ISO 17034:2016.

Indexed as

Dynamic mass flowNanomaterialNanoparticleParticle number concentrationReference materialSpICP-MS

Identifiers

PMID40055198
PMCPMC12170683

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.