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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