In the pharmaceutical industry, timing and certainty are everything. Time-to-market is a key driver for
newdrugs,andefficientbatch testing iscritical for releasingapprovedproducts.Whetherdevelopingnew
methods or conducting routine analysis, increasingproductivitydepends on choosing the right column
for the application. Rxi®-624Sil MS columns provide enhanced retention of polar compounds and
volatile analytes, aswell as fullMS compatibility,making them the best choice formanydrug analyses.
Fast, EffectiveMethodDevelopment
Often, 1 and5 type columns areused initially forGC/MSmethoddevelopment becauseof their thermal
stability; however, their nonpolar character results in poor retention for polar compounds, which
increases method development time. In contrast, effective methods can be developed quickly onmid
polarityRxi®-624SilMS columns, because they provide greater retention and selectivity for polar com-
pounds aswell as good thermal stability. For example,highlyvolatile,polar alkyl halide genotoxic impu-
rities are difficult to retain on 1s and 5s, but Rxi®-624SilMS columns provide the retention needed to
ensure adequate separation (Figure 4). Increased retentionmakesGC/MS analysis easier to control and
ultimately allows fastermethoddevelopment.
ImprovingResults forRoutineAnalysis
Onceadrug is approved, fast, reliablemethods areneeded for routinebatchanalysis.Establishing system
suitability is an important part of these procedures and a major factor in overall lab productivity.
Rxi®-624Sil MS columns provide the optimized selectivity and guaranteed reproducibility needed to
increase pass rates. For example, batch throughput can be improved for residual solvent testing under
USP <467> by using a column that provides increased resolution for system suitability components
(Figure 5). Greater resolution of critical pairs means higher system suitability pass rates, which allows
more batches tobe analyzedper shift.
Optimizedphase chemistry, complete columndeactivation, and tightly-controlledmanufacturingmake
Rxi®-624SilMS columns thebest choice formanypharmaceutical applications.Withbetter retentionof
polar volatiles, lower bleed, andhigher inertness, Rxi®-624SilMS columns can improve labproductivi-
ty by allowingnewmethods tobe developedquickly and routine applications tobe runmore reliably.
learn
more
Formore
pharmaceutical
applications on
Rxi
®
-624Sil MS
columns, visit
and download flyer
PHFL1245.
NEW!
Rxi
®
-624SilMSColumns:
AssureReliableSeparationofVolatile Impurities inPharmaceuticals
When running USP<467> by headspace, using a
smaller bore liner (1mm) can improve system suit-
ability pass rates. Larger bore liners (4 mm) are
usedwithdirect liquid injectionbecause the sample
is vaporized in the injection port and the linermust
be able to accommodate the solvent expansion vol-
ume. In contrast, inheadspaceanalysis, thesample
is vaporized ina vial insteadof the injectionport, so
a large volume liner is not needed, and in fact it can
be deleterious. In headspace methods, using a
smaller bore liner reduces band broadening by
increasing linear velocity, allowing faster sample
transfer and improving resolution.
TECHTIP!
4.30
4.40
4.50
4.60
4.70
4.80
Time (min)
1
2
1. Acetonitrile
2. Dichloromethane
GC_PH00912
ResolutionpassesUSP<467>criteriawhen
usinga1mm liner (red line), but fails if a4mm
liner isused (black line).
TimHerring, Technical Service Specialist
4
Website :
:
: 03 9762 2034 . . . inAUSTRALIA4
