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  1. Home
  2. Monitoring Residual Solvents In Pharmaceutical Products Using A Portable Pre-concentration Gc-pid.
  1. Home
  2. Monitoring Residual Solvents In Pharmaceutical Products Using A Portable Pre-concentration Gc-pid.

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Monitoring residual solvents in pharmaceutical products using a portable pre-concentration GC-PID.

Olajide Adetunji1, Sargun Kaur1, Nicole Wheeler1

  • 1Department of Chemistry, Center for Biomedical Research, Missouri University of Science and Technology, Rolla, MO 65409, USA.

Journal of Pharmaceutical and Biomedical Analysis
|August 1, 2024

View abstract on PubMed

Summary
This summary is machine-generated.

A new portable gas chromatography method rapidly analyzes residual solvents in pharmaceuticals. This quality control technique offers low detection limits and high accuracy, simplifying drug manufacturing safety checks.

Keywords:
On-line pre-concentrationPharmaceutical productsPortable GC with photoionization detectorVolatile residual solvents

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Science

Background:

  • Residual solvents in pharmaceuticals pose quality control and regulatory challenges.
  • Accurate monitoring of these solvents is crucial for patient safety and drug efficacy.

Purpose of the Study:

  • To develop a rapid, portable method for analyzing residual solvents in pharmaceutical products.
  • To establish a cost-effective quality control solution for drug manufacturing.

Main Methods:

  • Utilized a compact-portable gas chromatography with a photoionization detector (GC-PID).
  • Employed modified Tedlar® bag sampling and online pre-concentration.
  • Integrated miniaturized GC separation and micro-PID detection for direct analysis.

Main Results:

  • Achieved low method detection limits (26.00 - 52.03 pg/mL) for residual solvents.
  • Demonstrated rapid analysis time (5 min) with high linearity (r² < 0.99) and repeatability (RSD < 0.4%).
  • Validated method on over-the-counter drugs showed excellent accuracy (>91.2%) and precision (<6.5% RSD).

Conclusions:

  • The developed portable GC-PID method enables fast, accurate, and precise analysis of residual solvents.
  • This technique simplifies sample preparation, allowing direct analysis of solid pharmaceutical samples.
  • The method is suitable for in-process quality control during pharmaceutical manufacturing.