دورية أكاديمية
أعرض في EDS

Optimised quality control method for determination of the radiochemical purity of [ 99m Tc]Tc-mebrofenin and [ 99m Tc]Tc-etifenin in a clinical context.

التفاصيل البيبلوغرافية
العنوان: Optimised quality control method for determination of the radiochemical purity of [ 99m Tc]Tc-mebrofenin and [ 99m Tc]Tc-etifenin in a clinical context.
المؤلفون: Pirot C; Department of Nuclear Medicine, UNICAEN, Caen, France pirotcharlotte@gmail.com.; Department of Pharmacy, UNICAEN, Caen, France., Peyronnet D; Department of Nuclear Medicine, UNICAEN, Caen, France.; Department of Pharmacy, UNICAEN, Caen, France., Vigne J; Department of Nuclear Medicine, UNICAEN, Caen, France.; Department of Pharmacy, UNICAEN, Caen, France.; Normandie Université, UNICAEN, INSERM U1237, PhIND, Institut Blood and Brain @ Caen Normandie, Centre Cyceron, Caen 14000, France.
المصدر: European journal of hospital pharmacy : science and practice [Eur J Hosp Pharm] 2024 Jun 21; Vol. 31 (4), pp. 376-380. Date of Electronic Publication: 2024 Jun 21.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Country of Publication: England NLM ID: 101578294 Publication Model: Electronic Cited Medium: Print ISSN: 2047-9956 (Print) Linking ISSN: 20479956 NLM ISO Abbreviation: Eur J Hosp Pharm Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BMJ Publishing Group
مواضيع طبية MeSH: Organotechnetium Compounds*/standards , Organotechnetium Compounds*/analysis , Radiopharmaceuticals*/analysis , Radiopharmaceuticals*/standards , Quality Control*, Chromatography, Thin Layer/methods ; Chromatography, Thin Layer/standards ; Glycine/analysis ; Glycine/standards ; Glycine/chemistry ; Glycine/analogs & derivatives ; Reproducibility of Results ; Humans ; Aniline Compounds ; Hydroxyethylrutoside/analogs & derivatives
مستخلص: Objectives: In the context of a supply disruption of mebrofenin (Cholediam)-based kits for radiolabelling with technetium-99m [ 99m Tc], the medicine agencies allowed the importation of a back-up radiopharmaceutical diagnostic agent, etifenin (Techida), to ensure continuous management of patients with hepatobiliary disorders in nuclear medicine departments. There are still issues regarding the measurement of radiochemical purity (RCP) with these kits based on the European Pharmacopoeia and the Summary of Product Characteristics (SPC). This study aims to identify and to optimise, in a clinical context, the most suitable thin layer chromatography (TLC) method for the determination of the RCP in terms of speed of response and reliability for [ 99m Tc]Tc-mebrofenin and [ 99m Tc]Tc-etifenin.
Methods: [ 99m Tc]Tc-etifenin (n=4) and [ 99m Tc]Tc-mebrofenin (n=5) were individually controlled using six different TLC methods and one high-performance liquid chromatography (HPLC) method for impurity identification ([ 99m Tc](TcO 2 ) n and Na[ 99m Tc]TcO 4 ), RCP (%) and duration of analysis (min). Two TLC methods were selected according to the recommendations of the Pharmacopoeia and SPC, two others were exactly the same but with a heating step, and the other two corresponded to a mix between the methods of the SPC and the Pharmacopoeia that were chosen to optimise RCP determination parameters.
Results: Radio-HPLC analysis allowed effective separation of [ 99m Tc]Tc-etifenin and [ 99m Tc]Tc-mebrofenin with a retention time of 8.05±0.02 min and 8.94±0.07 min, respectively, from Na[ 99m Tc]TcO 4 (retention time 2.76±0.03 min). HPLC showed an absence of Na[ 99m Tc]TcO 4 for [ 99m Tc]Tc-mebrofenin and 0.2% for [ 99m Tc]Tc-etifenin. Among the TLC methods, we identified the most suitable method which ensures the most compliant RCP (98.3±0.9%) in a time of 31.5±1.1 min. Also, it allowed a time saving of 15 min compared with the methods proposed by the Pharmacopoeia and the SPCs.
Conclusion: We propose a TLC method that accelerates quality control by an average of 15 min while guaranteeing a reliable RCP.
Competing Interests: Competing interests: None declared.
(© European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
References: Eur J Nucl Med. 1979 Dec;4(6):445-8. (PMID: 520359)
Eur J Nucl Med. 1981;6(8):375-8. (PMID: 7308223)
Nucl Med Commun. 2010 Apr;31(4):280-5. (PMID: 20087241)
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فهرسة مساهمة: Keywords: nuclear medicine; pharmaceutical preparations; pharmacy service, hospital; practice guideline; quality control
المشرفين على المادة: 0 (Organotechnetium Compounds)
0 (Radiopharmaceuticals)
F2NQ468L52 (technetium Tc 99m mebrofenin)
TE7660XO1C (Glycine)
7Y4N11PXO8 (troxerutin)
0 (Aniline Compounds)
0 (Hydroxyethylrutoside)
تواريخ الأحداث: Date Created: 20230123 Date Completed: 20240621 Latest Revision: 20240725
رمز التحديث: 20240726
مُعرف محوري في PubMed: PMC11265548
DOI: 10.1136/ejhpharm-2022-003512
PMID: 36690417
قاعدة البيانات: MEDLINE
الوصف
تدمد:2047-9956
DOI:10.1136/ejhpharm-2022-003512