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Drug Concentrations: Measurements01:23

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Drug concentration is the quantity of a drug present in a biological sample. Measuring drug amounts in biological samples allows the clinician to understand how a drug is absorbed, distributed, metabolized, and excreted. Samples can be obtained through invasive or non-invasive methods. Invasive techniques involve surgical or parenteral interventions to gather blood, cerebrospinal fluid, or tissue biopsy. Conversely, non-invasive approaches provide samples like urine, feces, and saliva.
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Open Digital Reference Materials Unchain Controlled Substance Analysis.

Yu Tang1,2, Sinan Wang1, Cuifen Fang3

  • 1Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.

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Summary
This summary is machine-generated.

Digital reference materials (dRMs) replace physical ones for analyzing rare substances. Quantum mechanics-driven HifSA profiles offer portable, specific molecular referencing, proving effective for controlled Ephedra alkaloids.

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Area of Science:

  • Analytical Chemistry
  • Computational Chemistry
  • Pharmacognosy

Background:

  • Identical reference materials (iRMs) have limited availability and accessibility, hindering chemical analysis of rare and controlled substances.
  • Digital reference materials (dRMs) offer a conceptual solution by providing accessible and specific molecular data.
  • Quantum mechanics (QM)-driven 1H iterative functionalized spin analysis (HifSA) generates digital profiles ('nuclear genotype') of molecules.

Purpose of the Study:

  • To establish the proof-of-concept for using open dRMs to replace iRMs for controlled Ephedra alkaloids.
  • To demonstrate the field-scalable and portable nature of HifSA profiles for qualitative and quantitative analysis.
  • To expand the concept of open dRMs to a broader set of controlled substances.

Main Methods:

  • Generation of field-scalable HifSA profiles for controlled Ephedra alkaloids (ephedrine, pseudoephedrine, methylephedrine) using QM.
  • Application of HifSA profiles for the analysis of E. sinica and a multicomponent traditional Chinese medicine mixture.
  • Validation of QM-derived quantitative NMR (qHNMR) results using integral-based qHNMR (INT-qHNMR) and HPLC-UV.
  • Extension of the method to 12 congeneric phenylethylamines to create a set of open dRMs.
  • Comparison of two software tools (Cosmic Truth and ChemAdder) for HifSA profiling and QM-qHNMR analysis.

Main Results:

  • Successful proof-of-concept for replacing iRMs with open dRMs for controlled Ephedra alkaloids.
  • Demonstrated high specificity and instrumental portability of HifSA profiles across a range of magnetic field strengths (60-600 MHz).
  • Near-identical coupling constants (within 10 mHz) for monosubstituted benzenes validated the trueness of dRM profiles.
  • Established a starting set of open dRMs for 12 congeneric phenylethylamines within the controlled substances space.

Conclusions:

  • Open dRMs, generated via QM-driven HifSA, can effectively replace traditional iRMs for analyzing controlled substances.
  • The HifSA method provides portable and highly specific molecular referencing, advancing analytical capabilities.
  • This approach enhances the analytical toolbox for complex mixtures, enabling simultaneous identification and quantification, and promoting sustainability in analytical chemistry.