Page 12 - Shimadzu’s Solutions for Impurities Analysis

FDA Regulations on
Quantitation of Ultra-trace Impurities
Genotoxic Impurities
Co-Sense for Impurities

˙ Quantitation of Ultra-trace Impurities Using the Co-Sense for
Impurities System

High-sensitivity quantitation of impurities using trap Recommended Approaches." This method can fully exploit
concentration, 2D separation, and an absorbance detector is various separation conditions, such as phosphoric acid buffers
another approach to achieving the quantitation of ultra-trace and ion-pair reagents, to achieve separation and high-sensitivity
impurities required in the FDA draft guidance, "Genotoxic and quantitation of specific ultra-trace impurities. This can be
Carcinogenic Impurities in Drug Substances and Products: achieved by the Shimadzu Co-Sense for Impurities system.

FDA Regulations on
Genotoxic Impurities
˙ The Co-Sense for Impurities Analysis System Features

The Co-Sense for Impurities System, a combination of Step 2: Trap Concentration of Target Impurities
online-top concentration and 2D separation, achieves an
st
The eluted target impurity at the 1 dimensional phase is
approximately 20-fold increase in sensitivity over detection
introduced into the trap column. This effectively traps the
using only 1D separation. This enables ultra-high sensitivity
target impurity, making it diluted.
analysis with superior stability and lower running costs, even
when using conventional detectors such as an absorbance Step 3: Measurement of Target Impurities
detector.
The target impurities concentrated at the trap column are
Ultra-trace impurities, which were not adequately separated in
nd
introduced into the 2 dimensional separation to detect the
the 1st separation phase from either the main components or
target impurity with high-sensitivity. In addition, separation
other impurities, are reliably separated and can be accurately
Residual Solvents
of the main components or other impurities that cannot be
FDA Regulations on
quantified. This is achieved by using columns with different
st
separated in the 1 dimension is possible by changing the
retention characteristics for each separation or, alternatively, by
parameters between the dimensions. This ensures excellent
using different composition mobile phases.
analysis of ultra-trace impurities in conjunction with
Specialized software with a graphical user interface easily
concentration effect.
allows anyone to operate the system, from setting analytical
parameters to system cleaning.
Analysis Flow of the
Co-Sense for Impurities System
Step 1: Separation of Target Impurities
An ultra-trace target impurity is separated from main
components and other impurities in semi-preparative scale.
Inorganic Impurities
FDA Regulations on
When the eluting position of the target impurity is certain,
further separation is possible by changing the parameters at
nd
the 2 dimensional phase. In this case, complete separation
is not necessary. (Refer to Analysis of Impurities in
Pharmaceuticals in Page 13.)
Specialized software

Support from Shimadzu
System diagram

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