11_c190e214a - 第3页
Taking Online Dissolution Testing into the New Era of Ultra High Performance Chromatography Nexera ™ FV Provides Labor Savings and Faster Speeds in Dissolution T esting Dissolution tests are widely used in the pharmaceut…
Taking Online Dissolution Testing into the New Era
of Ultra High Performance Chromatography
Nexera
™
FV
Provides Labor Savings and Faster Speeds
in Dissolution Testing
Dissolution tests are widely used in the pharmaceutical development and quality control process and
for bioequivalence tests of generic drugs.
The Nexera FV provides substantial labor savings by automating processes ranging from the
dispensing of dissolution media to data acquisition and data analysis.
In addition, the system is based on the Nexera X3, renowned for its speed, sensitivity, and stability,
allowing users to quickly obtain reliable dissolution test results. The Nexera FV can also be used as a
standard UHPLC system, ensuring high laboratory throughput.
High-efficiency UHPLC delivers short analysis times
Unattended operation for overnight testing
Automated report creation enables quickly reviewing test results
Enables Testing of Quickly Dissolving Samples
Handles sampling intervals as short as five minutes
UHPLC analysis ensures quick generation of results
Substantial Improvements in Work Scheduling
Dedicated software drastically reduces the burden of preparing exam schedules
Multi-data report function simplifies the creation of reports
Taking Online Dissolution Testing into the New Era
of Ultra High Performance Chromatography
Nexera
™
FV
Provides Labor Savings and Faster Speeds
in Dissolution Testing
Dissolution tests are widely used in the pharmaceutical development and quality control process and
for bioequivalence tests of generic drugs.
The Nexera FV provides substantial labor savings by automating processes ranging from the
dispensing of dissolution media to data acquisition and data analysis.
In addition, the system is based on the Nexera X3, renowned for its speed, sensitivity, and stability,
allowing users to quickly obtain reliable dissolution test results. The Nexera FV can also be used as a
standard UHPLC system, ensuring high laboratory throughput.
High-efficiency UHPLC delivers short analysis times
Unattended operation for overnight testing
Automated report creation enables quickly reviewing test results
Enables Testing of Quickly Dissolving Samples
Handles sampling intervals as short as five minutes
UHPLC analysis ensures quick generation of results
Substantial Improvements in Work Scheduling
Dedicated software drastically reduces the burden of preparing exam schedules
Multi-data report function simplifies the creation of reports
System Configuration for Online Dissolution Testing
Two Analysis Modes Promote Faster Dissolution Testing
With the Nexera FV, the dissolution tester and the autosampler are connected online, so everything is automated from sampling
to dilution to data acquisition and analysis. As a result, there is less test-related work for the operator, and a subsequent increase
in processing throughput.
In addition, there is no manual dispensing of samples, ensuring reliable results.
Flow Vials Provide Automated Dissolution Testing
A dissolution medium from the dissolution tester flows
directly into flow vials loaded into the autosampler. A
bubble suppression design has been adopted for these
flow vials, enabling high-accuracy sampling of dissolution
media.
Depending on the dissolution tester used, 8 or 12 flow
vials can be loaded. Further, since the flow vials are
purposefully designed not to control the temperature, salt
precipitation from the dissolution medium is suppressed.
Dissolution
Tester
Analyze
Directly
Dissolution
Tester
Fractionate
Analyze
Direct Injection Analysis Mode: Exclusively with the Nexera System
In this mode, the dissolution medium delivered from the dissolution tester is directly loaded and analyzed. This is effective if the
analysis of the number of vessels finishes before the next sampling interval.
This analysis mode can be selected precisely because the Nexera FV is compatible with UHPLC analysis.
Fraction Analysis Mode: For Confirmation of Dissolution Profiles
at Short Sampling Intervals
This analysis mode is used for tests in which the sampling interval is short. This is suitable when checking the
dissolution profile of instantly soluble samples. The Nexera autosampler's high-speed performance makes this
system compatible with sampling intervals as short as five minutes. In addition, up to 768 samples can be
fractionated, making this mode effective when the dissolution quantity is large and dilution will be required.
Dissolution tester Filter station
Nexera FV
PC
Connected online
4
5