2.2.44. Total Organic Carbon in Water For Pharmaceutical Use
2.2.44. Total Organic Carbon in Water For Pharmaceutical Use
2.2.44. Total Organic Carbon in Water For Pharmaceutical Use
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2.2.46. CHROMATOGRAPHIC
SEPARATION TECHNIQUES
Chromatographic separation techniques are multi-stage
separation methods in which the components of a sample
are distributed between 2 phases, one of which is stationary,
while the other is mobile. The stationary phase may be a
solid or a liquid supported on a solid or a gel. The stationary
phase may be packed in a column, spread as a layer, or
distributed as a lm, etc. The mobile phase may be gaseous
or liquid or supercritical uid. The separation may be based
on adsorption, mass distribution (partition), ion-exchange,
etc., or may be based on differences in the physico-chemical
properties of the molecules such as size, mass, volume, etc.
This chapter contains denitions and calculations of common
parameters and generally applicable requirements for system
suitability. Principles of separation, apparatus and methods
are given in the following general methods :
paper chromatography (2.2.26) ;
thin-layer chromatography (2.2.27) ;
gas chromatography (2.2.28);
liquid chromatography (2.2.29) ;
size-exclusion chromatography (2.2.30) ;
supercritical uid chromatography (2.2.45).
DEFINITIONS
The system suitability and acceptance criteria in monographs
have been set using parameters as defined below. With some
equipment, certain parameters, such as the signal-to-noise ratio
and resolution, can be calculated using software provided by
the manufacturer. It is the responsibility of the user to ensure
that the calculation methods used in the software are equivalent
to the requirements of the European Pharmacopoeia and to
make any necessary corrections if this is not the case.
Chromatogram
A graphical or other representation of detector response,
efuent concentration or other quantity used as a measure
of efuent concentration, versus time or volume. Idealised
chromatograms are represented as a sequence of Gaussian
peaks on a baseline (Figure 2.2.46.-1).
Peak
The portion of a chromatogram recording the detector
response when a single component (or 2 or more unresolved
components) is eluted from the column.
See the information section on general monographs (cover pages)