Evidence map›Paper›PMID 41629489›Full record

ArticleAnalytical and bioanalytical chemistry2026

Analytical validation of an advanced U-HPLC-MS/MS method for lactose detection in food supplements and pharmaceuticals.

Alessandro Nencioni, Kristian Comelli, Michela Bulfoni, Emanuele Nencioni

Abstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Analytical and bioanalytical chemistry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Alessandro NencioniIBSA Institut Biochimique SA, Via del Piano, 29, CH-6915, Pambio Noranco, Switzerland.
Kristian ComelliBiofarma Group, Via Castelliere, 2, 33036, Mereto di Tomba, Udine, Italy.
Michela BulfoniDepartment of Medicine, University of Udine, 33100, Udine, Italy.
Emanuele NencioniBiofarma Group, Via Castelliere, 2, 33036, Mereto di Tomba, Udine, Italy. nencioni.emanuele@biofarmagroup.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Lactose intolerance is common, so accurate detection of lactose in supplements and pharmaceuticals is critical. We validated an ultra-high performance liquid chromatography-tandem mass spectrometry (U-HPLC-MS/MS) method with high sensitivity and specificity for trace lactose in products labeled "lactose-free." The workflow mitigates matrix effects through solid-phase extraction and filtration and explicitly accounts for α/β mutarotation to ensure correct identification and quantification. Validation per ISO and ICH Q2 confirmed robustness and performance superior to enzymatic/colorimetric assays for quality control and regulatory compliance. The method achieved excellent linearity (R

Indexed as

Dietary SupplementsLactoseLiquid Chromatography-Mass SpectrometryTandem Mass SpectrometryChromatography, High Pressure LiquidLimit of DetectionPharmaceutical PreparationsReproducibility of ResultsLactosePharmaceutical PreparationsAllergensDietary supplementsISO standardsLactoseMethod validationQuality controlU-HPLC–MS/MS technology

Identifiers

PMID41629489
PMCPMC13144169

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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.