LCGC UST
|Articles|February 1, 2005

LCGC Europe

  • LCGC Europe-02-01-2005
  • Volume 18
  • Issue 2

Taming the Regulatory Beast: Regulation versus Functionalism

The authors discuss the issue of meeting the demands of regulatory compliance whilst ensuring good scientific practice. A number of requirements from 21 CFR Part 11 are cited to demonstrate the importance of applying the principles of risk analysis.


Related to this article

Figure 2. Split injection used to measure triplicate test of MTBE, hexane, o-xylene, and 1-methylnaphthalene comparing different solvents (methanol, methylene chloride) and column insertion distances starting with 0.5 mm, 5.0 mm, 10.0 mm, 15 mm, and 20.0 mm. Methanol had the best performance at the 5.0 mm insertion distance and methylene chloride looked slightly better at the 0.5 mm. We would still recommend not going below the 5.0 mm manufacturer recommended insertion distance.
Revisiting insertion distance for methanol and methylene chloride in GC analysis and confirming that insertion depth strongly affects response and reproducibility.