Item request has been placed! ×
Item request cannot be made. ×
loading  Processing Request

Tetrabutylammonium HPLC analysis: shortcomings in the Ph. Eur. method.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
اقرأ على الانترنت اقرأ أكثر حفظ في قائمتي
  • معلومة اضافية
    • المصدر:
      Publisher: Wiley Country of Publication: England NLM ID: 7610510 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1099-1344 (Electronic) Linking ISSN: 03624803 NLM ISO Abbreviation: J Labelled Comp Radiopharm Subsets: PubMed not MEDLINE
    • بيانات النشر:
      Original Publication: London, New York, Wiley.
    • نبذة مختصرة :
      Tetrabutylammonium is a phase-transfer agent commonly used in PET radiochemistry. Its toxicity makes its quantification mandatory. However, the official HPLC method for tetrabutylammonium analysis reported in the European Pharmacopoeia (Ph. Eur.) apparently fails to achieve the described separation in most new generation reverse-phase columns. The study highlights the differences in separation achievable by varying some of the chromatographic conditions, such as temperature, eluent composition and ion-pairing agent concentration. In the end, variations to the method within the limits allowed by the Ph. Eur. were not sufficient to overcome the problem, thus forcing to a more radical change of the organic component of the mobile phase.
      (© 2019 John Wiley & Sons, Ltd.)
    • References:
      Meyer G-J, Waters SL, Coenen HH, Luxen A, Maziere B, Langstrom B. PET radiopharmaceuticals in Europe: current use and data relevant for the formulation of summaries of product characteristics (SPCs). Eur J Nucl Med. 1995;22(12):1420-1432.
      Kuntzsch M, Lamparter D, Brüggener N, Müller M, Kienzle GJ, Reischl G. Development and successful validation of simple and fast TLC spot tests for determination of Kryptofix® 2.2.2 and tetrabutylammonium in 18F-labeled radiopharmaceuticals. Pharmaceuticals. 2014;7(5):621-633.
      https://extranet.edqm.eu/4DLink1/4DCGI/Web_View/mono/20433.
      Fludeoxyglucose (18F) injection. European Pharmacopoeia 01/2014:1325.
      https://extranet.edqm.eu/4DLink1/4DCGI/Web_View/mono/1325.
      Poon J, Katsifis A, Fulham M. Alternate HPLC method for the analysis of tetrabutylammonium hydroxide in [18F]fluorodeoxythymidine (FLT). J Liq Chromatogr Relat Technol. 2017;40(13):667-670.
      Chromatographic separation techniques. European Pharmacopoeia 2.2.46.
    • Contributed Indexing:
      Keywords: European Pharmacopoeia; HPLC; fluorine-18; quality control; tetrabutylammonium
    • الموضوع:
      Date Created: 20191231 Latest Revision: 20240724
    • الموضوع:
      20240725
    • الرقم المعرف:
      10.1002/jlcr.3822
    • الرقم المعرف:
      31887241