Evidence map›Paper›PMID 29404042›Full record

ArticleJournal of pharmaceutical analysis2017

Identification and characterization of related substances in EVT-401 by hyphenated LC-MS techniques.

Binan Zhu, Yuting Lu, Leilin Chen, Binbin Yu, Yuexin Liu, Min Song, Taijun Hang

Open access · goldAbstract read
In one paragraph

Article in Journal of pharmaceutical analysis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 50% of its field
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

1 citing paper in PubMed, 9 citations in OpenAlex.

  1. P2XFrontiers in cellular neuroscience · 2021
    Review
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

7 authors at 4 institutions in 1 country.

Binan ZhuKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education; Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.
Yuting LuKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education; Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.
Leilin ChenDepartment of Chemical Drug Control, Hubei Institute for Food and Drug Control, Wuhan 430074, China.
Binbin YuDepartment of Pharmacy, Taizhou First People's Hospital, Taizhou 318200, China.
Yuexin LiuKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education; Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.
Min SongKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education; Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.
Taijun HangKey Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education; Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.
China Pharmaceutical University · CNMinistry of Education of the People's Republic of China · CNTaizhou First People's Hospital · CNZheJiang Institute For Food and Drug Control · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A sensitive and selective method was developed for the separation and characterization of related substances (RSs) in EVT-401 by hyphenated LC-MS techniques. Complete separation of the RSs was achieved with an Inertsil ODS-SP column (250 mm×4.6 mm, 5 µm) by linear gradient elution using a mobile phase consisting of 0.2% formic acid solution, methanol and acetonitrile. EVT-401 was found to be susceptible to acid, alkaline and oxidative stresses, while relatively stable under photolytic and thermal dry stress conditions. Fourteen RSs including six process-related substances and eight degradation products were detected and identified in EVT-401 with positive ESI high-resolution TOF-MS analysis of their parent ions and the corresponding product mass spectra elucidation, and some of them were further verified by chemical synthesis and NMR spectroscopy. The specific LC-MS method developed for separation, identification and characterization of RSs is valuable for EVT-401 manufacturing process optimization and quality control.

Indexed as

Degradation productsEVT-401LC–MSRelated substances

Identifiers

PMID29404042
PMCPMC5790700
OpenAlexW2597973996

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.