Evidence map›Paper›PMID 41380578›Full record

ArticleJournal of chromatography. A2026

The use of multiple liquid chromatography methods augmented by phosphorus-31 nuclear magnetic resonance to characterize the diastereomer composition in synthetic oligonucleotides.

Mohsin Ali, Akanksha Manghrani, Mirandia Szramowski, Ahmed M Abdel-Megied, Likan Liang, Nils F Aberg, Kui Yang, Kang Chen, Yan Wang, Deyi Zhang and 3 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of chromatography. A, 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
–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

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

13 authors.

Mohsin AliDepartment of Pharmaceutical Sciences, University of Maryland, School of Pharmacy, Baltimore, MD, 21201, USA; Faculty of Pharmaceutical Sciences, GC University Faisalabad, Punjab, Pakistan.
Akanksha ManghraniInstitute for Bioscience and Biotechnology Research, National Institute of Standards and Technology and the University of Maryland, 9600 Gudelsky Drive, Rockville, MD 20850, United States.
Mirandia SzramowskiDepartment of Pharmaceutical Sciences, University of Maryland, School of Pharmacy, Baltimore, MD, 21201, USA.
Ahmed M Abdel-MegiedDepartment of Pharmaceutical Sciences, University of Maryland, School of Pharmacy, Baltimore, MD, 21201, USA; Department of Pharmaceutical Sciences, Notre Dame of Maryland University, School of Pharmacy, Baltimore, MD 21210, USA.
Likan LiangDivision of Product Quality Assessment X, Office of Product Quality Assessment II, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, United States.
Nils F AbergDivision of Product Quality Assessment X, Office of Product Quality Assessment II, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, United States.
Kui YangDivision of Pharmaceutical Quality Research II, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, St Louis, MO 63110, United States.
Kang ChenDivision of Pharmaceutical Quality Research II, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, United States.
Yan WangDivision of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, United States.
Deyi ZhangDivision of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, United States.
Steven FletcherDepartment of Pharmaceutical Sciences, University of Maryland, School of Pharmacy, Baltimore, MD, 21201, USA.
Robert G BrinsonInstitute for Bioscience and Biotechnology Research, National Institute of Standards and Technology and the University of Maryland, 9600 Gudelsky Drive, Rockville, MD 20850, United States.
Jace W JonesDepartment of Pharmaceutical Sciences, University of Maryland, School of Pharmacy, Baltimore, MD, 21201, USA. Electronic address: jjones@rx.umaryland.edu.

Funding

FDA HHS U01 FD007651FDA HHS U01 FD008322
6 · The paper itself

Abstract

Synthetic oligonucleotide therapeutics represent a rapidly advancing class of drugs that target RNA to modulate gene expression. The phosphorothioate modification to the nucleic acid backbone is routinely used to increase resistance to enzymatic degradation and improve the pharmacological profile. Each phosphorothioate modification creates a stereogenic center, leading to the formation of diastereomers at every modified linkage. This results in a final drug product containing a complex and heterogenous mixture of diastereomers. With the increasing regulatory approval of synthetic oligonucleotide drug products, there is a pressing need to develop analytical methods that can characterize their diastereomer composition. We detail the use of four liquid chromatography methods complemented by

Indexed as

OligonucleotidesPhosphorothioate OligonucleotidesChromatography, High Pressure LiquidChromatography, LiquidMagnetic Resonance SpectroscopyPhosphorus IsotopesStereoisomerismOligonucleotidesPhosphorothioate OligonucleotidesPhosphorus Isotopes(31)P NMRChemical activatorsDiastereomersLiquid chromatographyOligonucleotide therapeutics

Identifiers

PMID41380578
PMCPMC12718448

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.