Concepedia

Impurity Method Development

Impurity Method Development is a systematic process in pharmaceutical analytical chemistry that involves designing, optimizing, and validating analytical procedures specifically to detect, identify, and quantify impurities in drug substances and products with sufficient sensitivity, selectivity, and robustness to meet regulatory quality requirements.

427

Publications

12.5K

Citations

1.7K

Authors

496

Institutions

Publications per year

2017–2026

83

Parents

Children

Publications

427

Wave Functions for Impurity Levels

G. F. Koster, J. C. Slater · Physical Review · 1954 · 803 citations

, , +11

Resolution of conglomerates with the assistance of tailor-made impurities. Generality and mechanistic aspects of the "rule of reversal". A new method for assignment of absolute configuration

Lia Addadi, S. Weinstein, E. Gati et al. · Journal of the American Chemical Society · 1982 · 184 citations

, , +8

Wave Functions for Impurity Levels

G. F. Koster, J. C. Slater · Physical Review · 1954 · 153 citations

, , +11

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

Technique for determining concentration profiles of boron impurities in substrates

J. F. Ziegler, G.W. Cole, J. E. E. Baglin · Journal of Applied Physics · 1972 · 142 citations

, , +10

1–5 of 427

Authors

1.7K

  1. JM
    J. Moses Babu

    Dr. Reddy's Laboratories (India), India

    9 publications · 212 citations

    9

    h-index

  2. KV
    K. Vyas

    Dr. Reddy's Laboratories (India), India

    7 publications · 159 citations

    7

    h-index

  3. KD
    Kevin D. Altria

    GlaxoSmithKline (United Kingdom), United Kingdom

    6 publications · 460 citations

    6

    h-index

  4. BP
    Benedetta Pasquini

    University of Florence, Italy

    5 publications · 160 citations

    5

    h-index

  5. SO
    Serena Orlandini

    University of Florence, Italy

    5 publications · 160 citations

    5

    h-index

1–5 of 1.7K

Institutions

496

  1. Dr. Reddy's Laboratories (India)

    Hyderabad, India

    14 h-index

    89 publications

    2.1K citations

  2. Jawaharlal Nehru Technological University, Hyderabad

    Hyderabad, India

    10 h-index

    14 publications

    330 citations

  3. Cairo University

    Giza, Egypt

    10 h-index

    35 publications

    1.1K citations

  4. GITAM University

    Visakhapatnam, India

    10 h-index

    17 publications

    472 citations

  5. Merck & Co., Inc., Rahway, NJ, USA (United States)

    Rahway, United States

    9 h-index

    41 publications

    1.1K citations

  6. Eli Lilly (United States)

    Indianapolis, United States

    9 h-index

    40 publications

    1.1K citations

  7. University of Belgrade

    Belgrade, Serbia

    8 h-index

    26 publications

    742 citations

  8. Gedeon Richter (Hungary)

    Budapest, Hungary

    7 h-index

    27 publications

    783 citations

1–8 of 496

Venues

  1. Journal of Pharmaceutical and Biomedical Analysis

    106 publications · 2.8K citations

    31

    h-index

  2. Journal of Chromatography A

    39 publications · 1.3K citations

    22

    h-index

  3. Chromatographia

    20 publications · 602 citations

    15

    h-index

  4. Talanta

    14 publications · 506 citations

    13

    h-index

  5. Forensic Science International

    12 publications · 379 citations

    12

    h-index

1–5