Concepedia

Impurity Control Limits

Impurity Control Limits is a regulatory science construct that specifies the maximum acceptable levels of impurities in pharmaceutical substances or products, distinguished by its role in ensuring patient safety through risk-based thresholds derived from toxicological and process-related data.

33

Publications

1K

Citations

317

Authors

102

Institutions

Publications per year

2017–2026

12

Variants

Impurity Specification Limits

Parents

Publications

33

Impurity control and removal in copper tankhouse operations

Shijie Wang · JOM · 2004 · 91 citations

, , +13

Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA)

Naomi L. Kruhlak, Marianne Schmidt, Roland Froetschl et al. · Regulatory Toxicology and Pharmacology · 2024 · 73 citations · Full text

, , +13

High-quality and high-purity homoepitaxial diamond (100) film growth under high oxygen concentration condition

Tokuyuki Teraji · Journal of Applied Physics · 2015 · 68 citations

, , +14

A program toward a fusion reactor

P.H. Rebut, M.L. Watkins, D.J. Gambier et al. · Physics of Fluids B Plasma Physics · 1991 · 67 citations

, , +17

Experimental based CO2 transport specification ensuring material integrity

Bjørn H. Morland, Arne Dugstad, Gaute Svenningsen · International journal of greenhouse gas control · 2022 · 62 citations · Full text

, , +17

1–5 of 33

Authors

317

  1. DM
    D. Mueller

    Princeton Plasma Physics Laboratory, United States

    2 publications · 51 citations

    2

    h-index

  2. SK
    S. Kaye

    Princeton Plasma Physics Laboratory, United States

    2 publications · 51 citations

    2

    h-index

  3. ED
    E. de la Luna

    Culham Science Centre, United Kingdom

    2 publications · 116 citations

    2

    h-index

  4. JP
    Joel P. Bercu

    Gilead Sciences (United States), United States

    2 publications · 70 citations

    2

    h-index

  5. RK
    R. Kaita

    Princeton Plasma Physics Laboratory, United States

    2 publications · 51 citations

    2

    h-index

1–5 of 317

Institutions

102

  1. Oak Ridge National Laboratory

    Oak Ridge, United States

    4 h-index

    16 publications

    319 citations

  2. Princeton Plasma Physics Laboratory

    Princeton, United States

    4 h-index

    49 publications

    1.4K citations

  3. Culham Science Centre

    Abingdon, United Kingdom

    2 h-index

    61 publications

    3.7K citations

  4. Charles University

    Prague, Czechia

    2 h-index

    10 publications

    137 citations

  5. Fusion (United States)

    Houston, United States

    2 h-index

    12 publications

    164 citations

  6. Japan Atomic Energy Agency

    Tōkai Mura, Japan

    2 h-index

    4 publications

    53 citations

  7. Princeton University

    Princeton, United States

    2 h-index

    32 publications

    1K citations

  8. Takeda (United States)

    Deerfield, United States

    2 h-index

    2 publications

    64 citations

1–8 of 102

Venues

  1. Journal of Nuclear Materials

    7 publications · 123 citations

    7

    h-index

  2. Nuclear Fusion

    4 publications · 131 citations

    4

    h-index

  3. Analytica Chimica Acta

    2 publications · 31 citations

    2

    h-index

  4. Organic Process Research & Development

    2 publications · 47 citations

    2

    h-index

  5. Materials science forum

    MSF · Book series · 1 publications · 26 citations

    1

    h-index

1–5