Development and Validation of an Ion-Pair Reverse-Phase High-Performance Liquid Chromatography-Electrospray Ionization Mass Spectrometry Method for Determination of Purity of Nusinersen for Quality Control of Drug Substance or Drug Product.

Mikhail Samoilov, Ekaterina Zubareva, Maksim Degterev

Abstract read

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Article in International journal of molecular sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited 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

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0 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

3 authors.

Mikhail SamoilovGenerium JSC, 14, Vladimirskaya Street, 601125 Volginskiy, Russia.ORCID 0000-0002-6967-0542

Ekaterina ZubarevaGenerium JSC, 14, Vladimirskaya Street, 601125 Volginskiy, Russia.ORCID 0000-0002-6178-0050

Maksim DegterevGenerium JSC, 14, Vladimirskaya Street, 601125 Volginskiy, Russia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this study, an ion-pair reverse-phase high-performance liquid chromatography-electrospray ionization mass spectrometry (RP-HPLC-ESI-MS) method was optimized and validated for purity determination for the quality control of the proposed generic nusinersen oligonucleotide drug substance and drug product. The optimization and considerations of sample preparation, chromatographic and mass spectrometry conditions are discussed. The limit of detection was 2.5 × 10

Indexed as

Chromatography, Reverse-PhaseOligonucleotidesSpectrometry, Mass, Electrospray IonizationChromatography, High Pressure LiquidDrug ContaminationLiquid Chromatography-Mass SpectrometryQuality ControlReproducibility of ResultsOligonucleotideselectrospray ionizationion-pair reverse-phase high-performance liquid chromatographymass spectrometryNusinersenoligonucleotidepurityQTOFtime-of-flight mass spectrometryvalidation

Identifiers

PMID41977479

DOI10.3390/ijms27073301

PMCPMC13072881

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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.