Post on 30-Jan-2021
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Alliance HPLC Dissolution System
Why Dissolution
scientists in today’s
laboratories utilize
dissolution testing when
they need to measure the
performance of a drug
product. since it is designed
to mimic the ingestion of a
drug product in the human
body, dissolution testing is an
important quality control tool
that helps to characterize the
active drug, the active drug’s
release, and the dissolution
from a dosage formulation.
T EST WIT H CONFIDENC E
The Waters® Alliance® HPLC Dissolution System is a high throughput, automated, online
HPLC platform for dissolution and drug release testing. The system automates the entire
test: from dropping the dosage form that starts the test, to sample acquisition, analysis,
and calculation of the results, to the management of report preparation and distribution.
Sample aliquots are transferred from single or dual dissolution baths directly into covered
vials held in the thermostatted compartment of the Separations Module. Analysis of the
samples, by either HPLC or Absorbance (flow injection), is synchronized with the time
schedule for sample acquisition, minimizing the total time required to complete the test
and increasing your sample throughput.
The Alliance HPLC Dissolution System features:
■■ High sample throughput
■■ Automated sample acquisition from a variety of dissolution baths
■■ Publication-quality report publisher
■■ Custom dissolution calculations
■■ Fully compliance ready
Compatible with a variety of dissolution baths, Waters Alliance HPLC Dissolution
System incorporates the e2695D Separations Module, transfer module,
detector, and up to two compatible dissolution baths. Empower®-based
dissolution software provides complete automation from a single keyboard.
DESIGNED FOR DISSOLUT ION
Advanced solvent and sample management
The Alliance HPLC Dissolution System is the industry’s first
HPLC platform that combines dissolution sampling and HPLC
analysis. The core of the system is the e2695D Separations
Module, whose integrated fluidics design provides optimized
control over the solvent and sample management processes,
allowing you the flexibility to meet your specific requirements.
The low dispersion design and the capability of automatically
conditioning and blending up to four eluents allows the system
to be used with high efficiency columns, providing fast and
accurate results for even your most complex formulations.
Samples are processed individually or as pooled samples
according to compendial procedures.
Methods are run by downloading sampling times and sample
aliquot volumes to the Waters Transfer Module. The transfer
module uses a microprocessor-controlled array of syringe
pumps to take dissolution samples from six or eight vessels
simultaneously, and transfer the samples into sealed vials
housed in the e2695D Separations Module.
Media replace
Bath B
Bath aVial in carousel from the
2695D Separations Module
B daC
Versatile media management
The system provides a number of choices for media management
to suit your specific dissolution testing needs. You can use the
following capabilities singly or in combination:
■■ recirculate – Recycles media, used for rinsing the sample
path, to dissolution vessels prior to drawing sample,
minimizing media lost during a test. Useful in
single-bath configurations.
■■ rapid sampling – Samples from a single bath, at shorter
intervals, allowing for faster sample times.
■■ Media replacement – The vessels, from one or two baths,
are maintained at a constant volume using a fresh
media reservoir.
Alliance Dissolution Fluidics – Here’s how it works. Valve A or B opens and the syringe plungers automatically descend, drawing sample from the vessels in Bath A or B into the syringe. Next, Valve D opens (Valve A or B closes) and the syringe plunger rises, transferring the sample into the vial or to waste. If performing media replace, Valve C opens and the syringe plunger descends, transferring media into the syringe. Finally, Valve A or B opens and transfers media back into the sample vessels.
Profile a wide range of dosages
Begin sample acquisition within the first
minute after the start of the dissolution
test; subsequent samples can be acquired
at intervals varying from two minutes to
several hours. The duration of the test can
extend from two minutes to 7200 minutes.
MAXIMUM P RODUCT IV IT Y
High sample throughput
When you have a large number of
samples to analyze, multi-bath
sampling offers the highest productivity
and the most cost-effective operation.
The Alliance Dissolution System
allows you to acquire and process
dissolution samples from up to two
dissolution baths (six to eight vessels
per bath).
Intuitive, easy-to-use interface
The easy-to-learn dissolution Sample
Set Wizard allows you to enter all of
your dissolution test parameters in an
easy-to-follow, step-by-step fashion.
A FLEXIBLE, COST EFFECTIVE PLATFORM
Ultimate system flexibility
The Alliance HPLC Dissolution System is based on the e2695D
Separations Module, which has the same advanced analytical
capabilities as standard Alliance HPLC systems. Therefore, the
Dissolution System can be used alternatively for both dissolution
and/or conventional HPLC analyses without re-configuring or
re-learning a new system.
Choice of analytical techniques
The system can be used as a common platform for both UV- and
HPLC-based dissolution. This allows you to easily alternate between
UV and HPLC analysis on the same sample set without having to
repeat the dissolution test. In addition, common compliance tools
and analysis calculations can be used for both platforms.
Choice of detection
No matter your analysis, the system can be used with whatever
detection technique you require. Waters offers a full line of detector
options, that can be used stand alone or in series to fit your need for
sensitive yet comprehensive dissolution analysis. Multi-detection can
be useful for the simultaneous analysis of actives or with compounds
of vastly different physiochemical properties.
A comparison of an HPLC and an online flow-injection UV Absorbance dissolution plot run on the same sample, illustrating the same result.
The Alliance HPLC Dissolution System, when coupled with multiple detection techniques, allows you to see all your peaks of interest during the same analysis without having to rerun samples or sacrifice sensitivity.
HPLC Conditions:
System: Alliance HPLC Dissolution
Sample: Ethinyl estradiol and norethindrone acetate
Mobile Phase: H2O/ACN 40:60
Column: Symmetry® C18 4.6 X 75 mm
Detection: Fluorescence Ex. 280 nm, Em. 312 nm, Photodiode Array UV 241.0 nm
Dissolution Conditions:
Media: 0.025 M Acetate buffer
pH 5.0/0.15% SDS
Volume: 600 mL
Apparatus: Two at 75 rpm
DO MORE WIT H YOUR RESULT S
Waters software solutions enable you to capitalize on the results generated by the Alliance HPLC Dissolution System. The easy-to-use dissolution
software seamlessly integrates with Empower Software and automates the entire dissolution process – from dissolution to sampling analysis
calculation and, finally, reporting. Its built-in relational database gives you the power to organize, store, and retrieve your data quickly and easily,
as well as the flexibility to create a variety of searching, tracking, filtering, and viewing criteria for enhanced productivity.
Designed to comply with your regulatory needs
The dissolution software is fully 21 CFR Part 11 compliant-ready.
It electronically stores detailed audit reports, maximizes security capabilities,
and assures the highest level of integrity for all of your tests.
Control charts for temperature and apparatus speed are plotted using the limits specified in international pharmacopoeia and provide documentation that the tests were conducted within the specified conditions.
The dissolution software can be used with other options, such as System Suitability, and allows you to easily track and trend data for all relevant method performance parameters. You’ll have a detailed account of the processing method and an accurate audit trail for regulatory compliance.
Integrated dissolution calculations
Dissolution-specific calculations can be automatically
performed within the dissolution software – no need for
external spreadsheet software! All of the equations used
to calculate results are validated and can be both printed
and viewed online for the purposes of independent
verification. If desired, you may also use the Custom
Fields capability to perform additional data reduction
with your equations.
Use Custom Fields for online comparison of dissolution profiles using the FDA’s Difference (f1) and Similarity (f2) determinations. These parameters are reported and stored with the rest of the test data.
Your reports can show as much detail or as little detail as you’d like. They can be saved in a variety
of formats and/or be distributed electronically.
Comprehensive, publication-quality reports
The dissolution software, when combined with Empower Software,
provides a variety of reporting functions so that your report
format choices are virtually limitless. You can report all of the
information (such as sampling times, media volume, temperature,
apparatus speed, and other parameters) in one report. Or, choose
to create custom reports tailored for the intended recipient.
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
Waters, Waters Quality Parts, Alliance, Empower, and Symmetry are registered trademarks of Waters Corporation. T he Science of What’s Possible is a trademark of Waters Corporation. All other trademarks are the property of their respective owners.
©2013 Waters Corporation. Produced in the U.S.A.February 2013 720000251EN VW-IGS
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