Concepedia

Process Impurity Source Analysis

Process Impurity Source Analysis is a systematic methodological framework used in pharmaceutical development to identify, characterize, and trace the origins of process-related impurities arising during synthesis or manufacturing, thereby distinguishing it from general impurity monitoring by its focus on root-cause determination and pathway elucidation.

17

Publications

660

Citations

79

Authors

27

Institutions

Publications per year

2017–2026

2

Parents

Publications

17

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

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

, , +12

Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals

Stephen Horne, Matthew D. Vera, Laxma R. Nagavelli et al. · Journal of Pharmaceutical Sciences · 2023 · 65 citations · Full text

, , +17

Precipitated Impurities of Fertilizers Prepared from Wet-Process Phosphoric Acid

A. W. Frazier, James P. Smith, J. R. Lehr · Journal of Agricultural and Food Chemistry · 1966 · 49 citations

, , +8

An Efficient and Impurity-Free Process for Telmisartan:  An Antihypertensive Drug

Kikkuru Srirami Reddy, Neti Srinivasan, Chinta Raveendra Reddy et al. · Organic Process Research & Development · 2006 · 42 citations

, , +14

Application of LC–MSn in conjunction with mechanism-based stress studies in the elucidation of drug impurity structure: Rapid identification of a process impurity in betamethasone 17-valerate drug substance

Min Li, Mingxiang Lin, Abu M. Rustum · Journal of Pharmaceutical and Biomedical Analysis · 2008 · 32 citations

, , +17

1–5 of 17

Authors

79

  1. AW
    A. W. Frazier

    Tennessee Valley Authority, United States

    3 publications · 93 citations

    3

    h-index

  2. JP
    James P. Smith

    McGill University, Canada

    2 publications · 79 citations

    2

    h-index

  3. JR
    J. R. Lehr

    Tennessee Valley Authority, United States

    2 publications · 79 citations

    2

    h-index

  4. IB
    Iwona Bujak

    Polish Academy of Sciences, Poland

    1 publications · 12 citations

    1

    h-index

  5. OM
    Olga Michalak

    Polish Academy of Sciences, Poland

    1 publications · 12 citations

    1

    h-index

1–5 of 79

Institutions

27

  1. Koneru Lakshmaiah Education Foundation

    Vijayawada, India

    1 h-index

    2 publications

    52 citations

  2. Zagazig University

    Zagazig, Egypt

    1 h-index

    2 publications

    62 citations

  3. European Medicines Agency

    Amsterdam, Netherlands

    1 h-index

    1 publications

    65 citations

  4. Hubei University of Technology

    Wuhan, China

    1 h-index

    2 publications

    40 citations

  5. CiVentiChem (United States)

    Cary, United States

    1 h-index

    2 publications

    24 citations

  6. United States Food and Drug Administration

    Silver Spring, United States

    1 h-index

    7 publications

    455 citations

  7. Institute of Organic Chemistry

    Warsaw, Poland

    1 h-index

    1 publications

    12 citations

  8. Analytical Services

    Falls Church, United States

    1 h-index

    1 publications

    32 citations

1–8 of 27

Venues

  1. Journal of Agricultural and Food Chemistry

    3 publications · 93 citations

    3

    h-index

  2. 3

    h-index

  3. Industrial & Engineering Chemistry Research

    1 publications · 28 citations

    1

    h-index

  4. Molecules

    1 publications · 12 citations

    1

    h-index

  5. Analytical Chemistry Research

    1 publications · 26 citations

    1

    h-index

1–5