A Testing Strategy for Genotoxic Impurities Which Are Potential Metabolites.

被引:0
|
作者
Zeller, A. [1 ]
Kirchner, S. [1 ]
Muster, W. [1 ]
Paehler, A. [1 ]
Rothfuss, A. [1 ]
Schadt, S. [1 ]
Singer, T. [1 ]
机构
[1] Roche, Basel, Switzerland
关键词
D O I
暂无
中图分类号
X [环境科学、安全科学];
学科分类号
08 ; 0830 ;
摘要
P48
引用
收藏
页码:S51 / S51
页数:1
相关论文
共 50 条
  • [21] Determination of nitrobenzene potential genotoxic impurities in nifedipine with GC-MS
    Zhao, Xinyu
    Li, Caixia
    Zeng, Hongxia
    Gu, Xiao
    Zheng, Jinqi
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2024, 248
  • [22] Removal of Electrophilic Potential Genotoxic Impurities Using Nucleophilic Reactive Resins
    Lee, Claire
    Helmy, Roy
    Strulson, Christopher
    Plewa, Jolanta
    Kolodziej, Elizabeth
    Antonucci, Vincent
    Mao, Bing
    Welch, Christopher J.
    Ge, Zhihong
    Al-Sayah, Mohammad A.
    ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2010, 14 (04) : 1021 - 1026
  • [23] Oxidative metabolites and genotoxic potential of mammalian and plant lignans in vitro
    Niemeyer, HB
    Metzler, M
    JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2002, 777 (1-2): : 321 - 327
  • [24] Approaches to Assessment, Testing Decisions, and Analytical Determination of Genotoxic Impurities in Drug Substances
    Pierson, Duane A.
    Olsen, Bernard A.
    Robbins, Avid K.
    DeVries, Keith M.
    Varie, David L.
    ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2009, 13 (02) : 285 - 291
  • [25] In vitro production of turmeric (Curcuma longa L.) microrhizomes as a potential source for secondary metabolites.
    Cousins, Matthew
    Adelberg, Jeffrey
    Chen, Feng
    Rieck, James
    IN VITRO CELLULAR & DEVELOPMENTAL BIOLOGY-ANIMAL, 2006, 42 : 21A - 21A
  • [26] A modular strategy for the testing and assessment of non-genotoxic carcinogens
    Louekari, Kimmo
    Jacobs, Miriam N.
    ARCHIVES OF TOXICOLOGY, 2024, 98 (08) : 2463 - 2485
  • [27] Prediction of Drug Degradation Pathways leading to Structural Alerts for Potential Genotoxic Impurities
    Raillard, Stephen P.
    Bercu, Joel
    Baertschi, Steven W.
    Riley, Christopher M.
    ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2010, 14 (04) : 1015 - 1020
  • [28] Identification, synthesis, and characterization of potential genotoxic impurities of sildenafil citrate drug substance
    P. Rajesh Reddy
    Sivanadh Musunuri
    D. Rama Sekhara Reddy
    V. Subrahmanyam Chittala
    V. N. S. Murthy P
    K. Krishnamohan
    Future Journal of Pharmaceutical Sciences, 6
  • [29] Analytical Strategy for Low-Level Estimation of Unstable Genotoxic Boronate Ester Impurities
    Kushwah, Bhoopendra Singh
    Gandhi, Santosh
    Purandharan, Devikumar
    Rajendran, Ashok Kumar
    Jayaraman, Karthik
    Mangalampalli, Venkata Phanikrishna Sharma
    Young, Joel
    Bajpai, Lakshmikant
    ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2024, 28 (07) : 2667 - 2676
  • [30] Identification, synthesis, and characterization of potential genotoxic impurities of sildenafil citrate drug substance
    Rajesh Reddy, P.
    Musunuri, Sivanadh
    Rama Sekhara Reddy, D.
    Chittala, V. Subrahmanyam
    Murthy, V. N. S. P.
    Krishnamohan, K.
    FUTURE JOURNAL OF PHARMACEUTICAL SCIENCES, 2020, 6 (01)