Concepedia

Excipient Impurity Analysis

Excipient Impurity Analysis is a systematic analytical methodology within pharmaceutical science that identifies, characterizes, and quantifies unintended residual or degradative substances in excipients to ensure their safety, quality, and compliance with regulatory standards.

10

Publications

260

Citations

66

Authors

32

Institutions

Publications per year

2017–2026

1

Parents

Publications

10

Elemental Impurities in Pharmaceutical Excipients

Gang Li, D.R Schoneker, Katherine L. Ulman et al. · Journal of Pharmaceutical Sciences · 2015 · 67 citations · Full text

, , +17

Compatibility of sildenafil citrate and pharmaceutical excipients by thermal analysis and LC–UV

Tamíris Amanda Júlio, Igor Fernando Zâmara, Jerusa S. Garcia et al. · Journal of Thermal Analysis and Calorimetry · 2012 · 47 citations

, , +15

An investigation into the use of stepwise isothermal high sensitivity DSC as a means of detecting drug-excipient incompatibility

S. A. Wissing, Duncan Q.M. Craig, S. A. Barker et al. · International Journal of Pharmaceutics · 2000 · 39 citations

, , +10

Trends in Excipient Safety Evaluation

Robert E. Osterberg, C.C DeMerlis, David W. Hobson et al. · International Journal of Toxicology · 2011 · 24 citations

, , +14

An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment

Ruth Boetzel, Agnieszka Ceszlak, C. Andrew Day et al. · Journal of Pharmaceutical Sciences · 2018 · 21 citations

, , +17

1–5 of 10

Authors

66

  1. LS
    Lance Smallshaw

    Apotex (Canada), Canada

    1 publications · 21 citations

    1

    h-index

  2. RB
    Ruth Boetzel

    University of East Anglia, United Kingdom

    1 publications · 21 citations

    1

    h-index

  3. MG
    Marcello G. Trevisan

    Universidade Federal de Alfenas, Brazil

    1 publications · 47 citations

    1

    h-index

  4. RH
    Radu Horga

    AstraZeneca (United Kingdom), United Kingdom

    1 publications · 21 citations

    1

    h-index

  5. AA
    Ashutosh Agarwal

    Chonnam National University, South Korea

    1 publications · 16 citations

    1

    h-index

1–5 of 66

Institutions

32

  1. Harley-Davidson (United States)

    Milwaukee, United States

    2 h-index

    2 publications

    91 citations

  2. Corning (United States)

    Corning, United States

    1 h-index

    3 publications

    201 citations

  3. GlaxoSmithKline (United Kingdom)

    London, United Kingdom

    1 h-index

    2 publications

    42 citations

  4. Roche (Switzerland)

    Basel, Switzerland

    1 h-index

    1 publications

    21 citations

  5. Takeda (Ireland)

    Wicklow, Ireland

    1 h-index

    1 publications

    21 citations

  6. MSD (Netherlands)

    Amsterdam, The Netherlands

    1 h-index

    3 publications

    63 citations

  7. IPEC-Americas

    Arlington, United States

    1 h-index

    2 publications

    134 citations

  8. Novartis (United States)

    New York, United States

    1 h-index

    2 publications

    42 citations

1–8 of 32

Venues

  1. Journal of Pharmaceutical Sciences

    2 publications · 88 citations

    2

    h-index

  2. 2

    h-index

  3. Journal of Thermal Analysis and Calorimetry

    1 publications · 47 citations

    1

    h-index

  4. Pharmaceutical Development and Technology

    1 publications · 10 citations

    1

    h-index

  5. International Journal of Pharmaceutics

    1 publications · 39 citations

    1

    h-index

1–5