Evidence map›Paper›PMID 38954240›Full record

ReviewTherapeutic innovation & regulatory science2024

Mutagenic Azido Impurities in Drug Substances: A Perspective.

Sumit S Chourasiya, Deepika Kathuria, Vipin Kumar, Kamlesh J Ranbhan

Abstract readReview
PubMed Publisher
In one paragraph

Review in Therapeutic innovation & regulatory science, 2024. 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
–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

1 citing paper in PubMed.

  1. Article
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.

Sumit S ChourasiyaDepartment of Process Research and Development, IOL Chemicals and Pharmaceutical Ltd., Barnala, Punjab, 148101, India. sumitchourasiya@iolcp.com.ORCID 0000-0002-0435-2068
Deepika KathuriaChandigarh College of Pharmacy, Chandigarh Group of Colleges, Landran, Punjab, 140307, India.
Vipin KumarDepartment of Process Research and Development, IOL Chemicals and Pharmaceutical Ltd., Barnala, Punjab, 148101, India.
Kamlesh J RanbhanDepartment of Process Research and Development, IOL Chemicals and Pharmaceutical Ltd., Barnala, Punjab, 148101, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Contamination of drug products and substances containing impurities is a significant concern in the pharmaceutical industry because it may impact the quality and safety of medicinal products. Special attention is required when mutagenic impurities are present in pharmaceuticals, as they may pose a risk of carcinogenicity to humans. Therefore, controlling potential mutagenic impurities in active pharmaceutical ingredients to an acceptable safety limit is mandatory to ensure patient safety. As per the International Council for Harmonization (ICH) M7 (R2)

Indexed as

Drug ContaminationMutagensHumansMutagensAzido impuritiesDrug product recallMutagenicRegulatorySartans

Identifiers

PMID38954240

What OpenQuestion holds

Textmetadata
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.