Highlights
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Complete automated on line UV solution
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In-situ fiber optic probes - no liquid handling
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Complete spectral profiles, even for IR formulations
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Little time / labor between runs
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IQ OQ PQ available for the system
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Easy testing, validation and reporting
The Varian and
C Technologies Team
Varian's UV spectroscopy and dissolution capabilities and
C Technologies' specialization in fiber optic probe technology
have been
combined
to create the IO fiber optic UV dissolution system. IO harnesses the power
of the new fiber optic technology in a fully integrated and validated solution.
Complete Dissolution Solution
The IO system includes a computer, monitor, printer, Cary 50 Spectrophotometer
with multiplexer, fiber optic probes and your choice of Varian dissolution
tester. It is available in single- or dual-bath configurations.
Method-based System
The software allows you to run preprogrammed methods. A powerful sequencer
automatically guides the operator through system setup and data acquisition.
Once a run is started, operation is totally automated, even including printing
a report at the end of the run.
Complete Dissolution Profile
Collect a complete UV spectrum from each vessel for every time point, as rapidly
as every minute. You can specify multiple temporal regions in the run, each
of which has a different data collection rate. This allows you to collect
more data when the absorbance is changing quickly and to have fewer data
points in the more stable parts of the dissolution profile.
Automatic Correction for Excipient Effects
Multiple software algorithms correct for any effects due to absorbance or scattering
from excipients, undissolved capsules, surfactants, or anything else in the
vessel other than the active.
Reporting Solution
A comprehensive report can be tailored for your specific reporting needs. Graphics
showing percent dissolved versus time, and absorbance versus wavelength versus
time can be included in a report. Also include in the report are both raw
and corrected data, and a complete set of statistics. Finally, your dissolution
reports can included your company logo or any bitmap you choose.
Audit trails are logged, providing information about how the data was collected
and calculated.
GLP Compliance
GLP application is used to set up different privileges for the users in your
laboratory and to comply with Good Laboratory Practice.
21 CFR Part 11 Compliance
We are committed to providing a system meeting this regulatory
requirement. For an update on the current system, please check the Varian
Web site at www.varianinc.com.
Optimized Probes
The IO fiber optic probes were specifically designed for dissolution. Their
interchangeable tips allow using one probe for all your dosage strengths.
Their thin cross-section minimizes hydrodynamic effects, which can be totally
eliminated by using the system to automatically withdraw the probes when
they are not taking measurements.
Cary 50 Spectrophotometer and Cassini Multiplexer
The Cary 50 Xenon lamp allows 80 data points per second.
The Xenon lamp flashes only when acquiring a data point, unlike a diode array
which exposes the sample to the whole wavelength range with each reading, causing
degradation of photosensitive samples.
The Cary 50 is unaffected by room light. It can be operated with the sample
compartment opened or closed. The 12 probe Cassini multiplexer easily handles
either 1 or 2 dissolution baths.
Software Components
The IO software is designed to run on Windows NT Workstations.
Software applications allow you to:
- Create and store custom methods, which include equipment
parameters
- Perform routine wavelength scanning measurements
- Scan the photometric values of samples over an entire wavelength
range
- Automatically correct for the effects of excipients on the
data
- Export data as an ASCII file for further data manipulation
System Qualification
We offer a complete qualification guide of the entire system (spectrophotometer,
multiplexer, probes, dissolution tester and dissolution protocols). This
guide is available to you as is the qualification service by one of our laboratory
chemists. Our Laboratory Services Team can perform the qualification of the
complete system for you. Call for details about our service capabilities.