Concepedia

Impurity Specification Setting

Impurity Specification Setting is a methodological framework within impurity risk assessment that establishes acceptable thresholds for impurities by integrating scientific rationale, regulatory guidelines, and risk-based evaluation to ensure product safety and quality.

8

Publications

194

Citations

43

Authors

27

Institutions

Publications per year

2017–2026

3

Parents

Publications

8

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

Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities

Joel P. Bercu, Susan C. Berlam, John C. Berridge et al. · Journal of Pharmaceutical Innovation · 2018 · 42 citations · Full text

, , +12

Critical review on establishment and availability of impurity and degradation product reference standards, challenges faced by the users, recent developments, and trends

Dilip Kumar Singh, Archana Sahu, Sanjay Kumar et al. · TrAC Trends in Analytical Chemistry · 2017 · 26 citations

, , +16

Impact of CO2 Specifications on Design and Operation Challenges of CO2 Transport and Storage Systems in CCUS

Mahmoud Nazeri, Hooman Haghighi, Craig Mckay et al. · 2021 · 17 citations

, , +15

Impurity control in liquid lithium loop for IFMIF target facility

Y. Kato, H Katsuta, Satoshi Konishi et al. · Journal of Nuclear Materials · 1998 · 11 citations

, , +9

1–5 of 8

Authors

43

  1. SZ
    Suling Zhai

    University of Cambridge, United Kingdom

    1 publications · 17 citations

    1

    h-index

  2. GB
    Giovanni Boccardi

    Sanofi (Italy), Italy

    1 publications · 11 citations

    1

    h-index

  3. SK
    Satoshi Konishi

    Kyoto University, Japan

    1 publications · 11 citations

    1

    h-index

  4. BC
    Barry Cherney

    National Cancer Institute, United States

    1 publications · 42 citations

    1

    h-index

  5. CA
    Christophe Agut

    Sanofi (France), France

    1 publications · 11 citations

    1

    h-index

1–5 of 43

Institutions

27

  1. Amgen (United States)

    Thousand Oaks, United States

    1 h-index

    1 publications

    42 citations

  2. Janssen (Ireland)

    Dublin, Ireland

    1 h-index

    1 publications

    42 citations

  3. Novartis (Switzerland)

    Basel, Switzerland

    1 h-index

    1 publications

    10 citations

  4. Tecnologia Energia Ambiente Materiali (Italy)

    Ispra, Italy

    1 h-index

    1 publications

    11 citations

  5. Tunnell Consulting

    King of Prussia, United States

    1 h-index

    1 publications

    42 citations

  6. Land Quality Management

    Nottingham, United Kingdom

    1 h-index

    1 publications

    42 citations

  7. Westinghouse Electric (United States)

    Cranberry Township, United States

    1 h-index

    1 publications

    11 citations

  8. Pfizer (United States)

    New York, United States

    1 h-index

    4 publications

    168 citations

1–8 of 27

Venues

  1. 2

    h-index

  2. TrAC Trends in Analytical Chemistry

    1 publications · 26 citations

    1

    h-index

  3. Educational and Psychological Measurement

    1 publications · 10 citations

    1

    h-index

  4. Journal of Nuclear Materials

    1 publications · 11 citations

    1

    h-index

  5. Journal of Pharmaceutical Innovation

    1 publications · 42 citations

    1

    h-index

1–5