IDEAS home Printed from https://ideas.repec.org/a/bjc/journl/v12y2025i9p3828-3836.html
   My bibliography  Save this article

A Review on Synthesis and Biological Activities of Nitrosamine Impurities in Active Pharmaceutical Ingredients (APIs)

Author

Listed:
  • Pooja S Dalvi

    (Ph.D. Scholar, Department of Chemistry, Patkar-Varde College, Goregaon West, Mumbai-61)

  • Sharad S Sankhe

    (Head of Department, Department of Chemistry, Patkar-Varde College, Goregaon West, Mumbai-61)

Abstract

Nitrosamine impurities are chemical compounds that can unintentionally form in active pharmaceutical ingredient during manufacturing or storage. Nitrosamine are carcinogenic and genotoxic. Nitrosamines are a group of nitroso compounds that can be formed when secondary or tertiary amine from API like-Lansoprazole, Dasatinib, Nilotinib or Oxybutynin react with nitrosating agents like NaNO2 in acidic medium or Tert-butyl nitrite etc. Validated analytical methods are used for identification and quantification these impurities. Highly sensitive instruments like High performance liquid chromatography (HPLC) and Gas chromatography (GC) required for quantification of these impurities and Mass Spectroscopy (MS) and Nuclear Magnetic Resonance (NMR) are required for identification, these impurities have certain limit which can be detected on these instruments.

Suggested Citation

  • Pooja S Dalvi & Sharad S Sankhe, 2025. "A Review on Synthesis and Biological Activities of Nitrosamine Impurities in Active Pharmaceutical Ingredients (APIs)," International Journal of Research and Scientific Innovation, International Journal of Research and Scientific Innovation (IJRSI), vol. 12(9), pages 3828-3836, August.
    • Handle: RePEc:bjc:journl:v:12:y:2025:i:9:p:3828-3836
    as

    Download full text from publisher

    File URL: https://www.rsisinternational.org/journals/ijrsi/uploads/vol12-iss9-pg3828-3836-202510_pdf.pdf
    Download Restriction: no
    File URL: https://www.rsisinternational.org/journals/ijrsi/article.php?id=411
    Download Restriction: no
    ---><---

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:bjc:journl:v:12:y:2025:i:9:p:3828-3836. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Dr. Renu Malsaria (email available below). General contact details of provider: https://rsisinternational.org/journals/ijrsi/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.