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Related Concept Videos

Sampling Methods: Sample Types01:18

Sampling Methods: Sample Types

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Sampling materials are classified into three main types: solid, liquid, and gas.
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Accurate calibration of glassware, such as volumetric flasks, pipettes, and burettes, is essential to ensure accurate measurements in the analytical laboratory. Calibration helps maintain consistency across measurements and prevents errors arising from inaccurate volumes.
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Contaminants and Errors01:16

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Effective sample preparation is crucial for accurate and reliable laboratory analysis. During this process, two significant sources of error can arise: concentration bias from improper sample splitting and contamination caused by methods used to reduce particle size, such as grinding or homogenization. Identifying and minimizing these potential errors is crucial to ensuring the validity of the analysis.
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Quantitative Detection of Trace Explosive Vapors by Programmed Temperature Desorption Gas Chromatography-Electron Capture Detector
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Potential Sampling Errors in Stability Studies Due to Dead Volume in Closed System Transfer Devices.

Mélanie Closset1,2,3, Maire-Lise Colsoul1,3, Benoît Bihin2,4

  • 1Medical Laboratory, CHU UCL NAMUR, Yvoir, Belgium.

The Journal of Pharmacy Technology : Jpt : Official Publication of the Association of Pharmacy Technicians
|November 7, 2024
PubMed
Summary

Closed system transfer devices (CSTDs) may introduce bias in anticancer drug stability studies. The Tevadaptor® device overestimated gemcitabine concentrations in initial samples, highlighting the need for understanding CSTD technical specifications.

Keywords:
Anticancer drugClosed system transfer device (CSTD)Liquid chromatographyStability studyTevadaptor®

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Stability Testing
  • Analytical Chemistry

Background:

  • Closed system transfer devices (CSTDs) are utilized to minimize healthcare professional exposure to hazardous drugs.
  • Their application in stability studies for anticancer drugs, such as gemcitabine, is common.
  • A specific CSTD, Tevadaptor®, was investigated for potential bias in gemcitabine stability assessments.

Observation:

  • Initial aliquots of gemcitabine withdrawn using the Tevadaptor® CSTD showed a significant overestimation in concentration (26%) compared to expected values.
  • This overestimation was not observed in subsequent aliquots withdrawn from the same bags using the same device.
  • Using a needle instead of the CSTD to withdraw aliquots did not result in concentration overestimation.

Findings:

  • The Tevadaptor® device introduced a statistically significant positive bias in the measured concentration of the first gemcitabine aliquots.
  • The bias was specific to the initial withdrawal and not present in later samples or when using a needle.
  • The study suggests a potential interaction or issue with the CSTD during the initial drug withdrawal process.

Implications:

  • The findings underscore the critical importance of validating the performance of CSTDs in drug stability studies.
  • Misinterpretation of stability data due to CSTD-induced bias could impact drug quality assessments and regulatory compliance.
  • A thorough understanding of CSTD technical specifications and potential limitations is essential for accurate pharmaceutical analysis.