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Development and Validation of an Innovative Analytical Approach for the Quantitation of Tris(Hydroxymethyl)Aminomethane (TRIS) in Pharmaceutical Formulations by Liquid Chromatography Tandem Mass Spectrometry.
Madmon, Moran; Shamai Yamin, Tamar; Pitel, Shani; Belay, Chen; Segula, Yaniv; Toister, Einat; Hindi, Ariel; Cherry, Lilach; Ophir, Yakir; Zichel, Ran; Mimran, Avishai; Diamant, Eran; Weissberg, Avi.
  • Madmon M; Department of Analytical Chemistry, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Shamai Yamin T; Department of Analytical Chemistry, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Pitel S; Department of Biotechnology, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Belay C; Department of Analytical Chemistry, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Segula Y; Department of Biotechnology, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Toister E; Department of Biotechnology, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Hindi A; Department of Analytical Chemistry, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Cherry L; Department of Biotechnology, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Ophir Y; Department of Biotechnology, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Zichel R; Department of Biotechnology, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Mimran A; Department of Biotechnology, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Diamant E; Department of Biotechnology, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
  • Weissberg A; Department of Analytical Chemistry, Israel Institute for Biological Research (IIBR), P.O. Box 19, Ness Ziona 7410001, Israel.
Molecules ; 28(1)2022 Dec 22.
Article in English | MEDLINE | ID: covidwho-2242985
ABSTRACT
A novel COVID-19 vaccine (BriLife®) has been developed by the Israel Institute for Biological Research (IIBR) to prevent the spread of the SARS-CoV-2 virus throughout the population in Israel. One of the components in the vaccine formulation is tris(hydroxymethyl)aminomethane (tromethamine, TRIS), a buffering agent. TRIS is a commonly used excipient in various approved parenteral medicinal products, including the mRNA COVID-19 vaccines produced by Pfizer/BioNtech and Moderna. TRIS is a hydrophilic basic compound that does not contain any chromophores/fluorophores and hence cannot be retained and detected by reverse-phase liquid chromatography (RPLC)-ultraviolet (UV)/fluorescence methods. Among the few extant methods for TRIS determination, all exhibit a lack of selectivity and/or sensitivity and require laborious sample treatment. In this study, LC−mass spectrometry (MS) with its inherent selectivity and sensitivity in the multiple reaction monitoring (MRM) mode was utilized, for the first time, as an alternative method for TRIS quantitation. Extensive validation of the developed method demonstrated suitable specificity, linearity, precision, accuracy and robustness over the investigated concentration range (1.2−4.8 mg/mL). Specifically, the R2 of the standard curve was >0.999, the recovery was >92%, and the coefficient of variance (%CV) was <12% and <6% for repeatability and intermediate precision, respectively. Moreover, the method was validated in accordance with strict Good Manufacturing Practice (GMP) guidelines. The developed method provides valuable tools that pharmaceutical companies can use for TRIS quantitation in vaccines and other pharmaceutical products.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Diagnostic study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal subject: Biology Year: 2022 Document Type: Article Affiliation country: Molecules28010073

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Diagnostic study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal subject: Biology Year: 2022 Document Type: Article Affiliation country: Molecules28010073