Concepedia

Impurity Assay Development

Impurity Assay Development is a methodological framework within analytical chemistry that specifically enables the precise identification, characterization, and quantification of impurities in a substance through the systematic design and validation of selective, sensitive, and robust analytical assays.

83

Publications

2.4K

Citations

301

Authors

114

Institutions

Publications per year

2017–2026

17

Parents

Publications

83

The importance of impurity analysis in pharmaceutical products: an integrated approach

Nafisur Rahman, Syed Najmul Hejaz Azmi, Hui‐Fen Wu · Accreditation and Quality Assurance · 2006 · 182 citations

, , +16

Recent advances in the determination of elemental impurities in pharmaceuticals – Status, challenges and moving frontiers

V. Balaram · TrAC Trends in Analytical Chemistry · 2016 · 151 citations

, , +16

Essential peak area normalisation for quantitative impurity content determination by capillary electrophoresis

Kevin D. Altria · Chromatographia · 1993 · 142 citations

, , +16

Strategies for organic impurity quantification by 1H NMR spectroscopy: Constrained total-line-shape fitting

Pasi Soininen, Jorma Haarala, Jouko Vepsäläinen et al. · Analytica Chimica Acta · 2005 · 79 citations

, , +16

A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603)

Peter F. Gavin, Bernard A. Olsen · Journal of Pharmaceutical and Biomedical Analysis · 2007 · 67 citations

, , +14

1–5 of 83

Authors

301

  1. KD
    Kevin D. Altria

    GlaxoSmithKline (United Kingdom), United Kingdom

    3 publications · 215 citations

    3

    h-index

  2. HY
    Hassan Y. Aboul‐Enein

    National Research Centre, Egypt

    2 publications · 41 citations

    2

    h-index

  3. BA
    Bernard A. Olsen

    Eli Lilly (United States), United States

    2 publications · 116 citations

    2

    h-index

  4. SG
    Sándor Gǒrög

    Gedeon Richter (Hungary), Hungary

    2 publications · 59 citations

    2

    h-index

  5. MG
    M. Gazdag

    Gedeon Richter (Hungary), Hungary

    2 publications · 59 citations

    2

    h-index

1–5 of 301

Institutions

114

  1. Eli Lilly (United States)

    Indianapolis, United States

    3 h-index

    10 publications

    351 citations

  2. Gedeon Richter (Hungary)

    Budapest, Hungary

    2 h-index

    9 publications

    267 citations

  3. Alexandria University

    Alexandria, Egypt

    2 h-index

    5 publications

    100 citations

  4. Institute of Group Analysis

    London, United Kingdom

    2 h-index

    2 publications

    172 citations

  5. National Research Centre

    Giza, Egypt

    2 h-index

    2 publications

    41 citations

  6. Agricultural Research Center

    Giza, Egypt

    1 h-index

    1 publications

    25 citations

  7. Experimental Station

    Chicago, United States

    1 h-index

    5 publications

    50 citations

  8. Institut Pasteur de Lille

    Lille, France

    1 h-index

    3 publications

    63 citations

1–8 of 114

Venues

  1. 16

    h-index

  2. Journal of Chromatography A

    7 publications · 131 citations

    7

    h-index

  3. Analytica Chimica Acta

    5 publications · 165 citations

    5

    h-index

  4. Chromatographia

    4 publications · 242 citations

    4

    h-index

  5. TrAC Trends in Analytical Chemistry

    3 publications · 266 citations

    3

    h-index

1–5