Concepedia

Impurity Method Validation

Impurity Method Validation is an analytical method validation process that systematically and prospectively demonstrates, through predefined performance characteristics, that a specific analytical procedure is suitable, reliable, and reproducible for the detection, identification, and quantitative determination of impurities in a defined drug substance or drug product.

510

Publications

13K

Citations

1.9K

Authors

577

Institutions

Publications per year

2017–2026

112

Parents

Children

Publications

510

Dioxin and dioxin-like PCB impurities in some Japanese agrochemical formulations

Shigeki Masunaga, Takumi Takasuga, Junko Nakanishi · Chemosphere · 2001 · 236 citations

, , +12

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

Validation of chromatographic methods: Evaluation of detection and quantification limits in the determination of impurities in omeprazole

Marcelo Ribani, Carol H. Collins, Carla Beatriz Grespan Bottoli · Journal of Chromatography A · 2006 · 151 citations

, , +14

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

Kevin D. Altria · Chromatographia · 1993 · 142 citations

, , +16

Validation of a capillary electrophoresis method for the determination of a quinolone antibiotic and its related impurities

Kevin D. Altria, Y.L. Chanter · Journal of Chromatography A · 1993 · 105 citations

, , +12

1–5 of 510

Authors

1.9K

  1. NK
    Naresh Kumar Katari

    GITAM University, India

    9 publications · 354 citations

    9

    h-index

  2. KM
    K. Mukkanti

    Jawaharlal Nehru Technological University, Hyderabad, India

    7 publications · 145 citations

    7

    h-index

  3. JM
    J. Moses Babu

    Dr. Reddy's Laboratories (India), India

    7 publications · 169 citations

    7

    h-index

  4. YV
    Yvan Vander Heyden

    Vrije Universiteit Brussel, Belgium

    7 publications · 250 citations

    7

    h-index

  5. TD
    Thirupathi Dongala

    GITAM University, India

    7 publications · 240 citations

    7

    h-index

1–5 of 1.9K

Institutions

577

  1. Dr. Reddy's Laboratories (India)

    Hyderabad, India

    16 h-index

    95 publications

    2.2K citations

  2. GITAM University

    Visakhapatnam, India

    14 h-index

    37 publications

    1.2K citations

  3. Cairo University

    Giza, Egypt

    14 h-index

    42 publications

    1.2K citations

  4. Jawaharlal Nehru Technological University, Hyderabad

    Hyderabad, India

    14 h-index

    26 publications

    570 citations

  5. Beni-Suef University

    Banī Suwayf, Egypt

    10 h-index

    28 publications

    511 citations

  6. Dr. Reddy's Laboratories (United States)

    Princeton, United States

    10 h-index

    23 publications

    420 citations

  7. Vrije Universiteit Brussel

    Brussels, Belgium

    8 h-index

    24 publications

    1K citations

  8. Centre National de la Recherche Scientifique

    Paris, France

    7 h-index

    29 publications

    1K citations

1–8 of 577

Venues

  1. Journal of Pharmaceutical and Biomedical Analysis

    103 publications · 2.7K citations

    30

    h-index

  2. Journal of Chromatography A

    43 publications · 1.7K citations

    24

    h-index

  3. Chromatographia

    21 publications · 661 citations

    17

    h-index

  4. Analytica Chimica Acta

    19 publications · 396 citations

    13

    h-index

  5. Forensic Science International

    15 publications · 514 citations

    13

    h-index

1–5