First Time Quality and

Laboratory Productivity
with Waters NextGen LC

©2023 Waters Corporation 1

 The Alliance™ iS
HPLC System
didn’t start in our
lab.

It started in yours.

©2023 Waters Corporation 2

Placing Customer Needs at the Heart of the Design
What you are telling us

Reduction Smooth method Reduction Simplified fleet Consistency in

in errors in transfer in instrument management operation
QC downtime

©2023 Waters Corporation 3

What Our Customers Are Telling Us

The Pharma QC customers

we surveyed told us that
Human errors
account for up to

40%
of their quality incidents
and related problems

CXKM Global Survey: Average of 56 QC Customers with >25 HPLC Systems

©2023 Waters Corporation 4
Estimating the Cost of Human Error

12-24 Deviations per

lab every year
Up to

$2.5M
$10K Cost per deviation Cost of investigating deviations for 10
labs in 1 year

©2023 Waters Corporation 5

©2023 Waters Corporation 6
©2023 Waters Corporation 7
Step Change the
Performance of Your Lab
Achieve First Time Quality (FTQ)
with the Alliance iS HPLC System

 Intuitively prevents up to 40% of common

errors
 Provide fast, simple guidance at the point of
need
 Boost productivity & efficiency through
effective resource utilization
 Drive workflow efficiencies & quality
improvements
 Improve data integrity

©2023 Waters Corporation 8

The System: Intuitively Simple

System status lighting & Intuitive

color-coded flags and touchscreen
clips

Help at your fingertips

Made for Empower™
Software
Intelligent Method
Translator App
waters_connect™ System
Monitoring
Smart column
capabilities

©2023 Waters Corporation 9

Intuitive Touchscreen
System Overview

©2023 Waters Corporation 10

Intuitive Touchscreen
Guided Instrument Startup

©2023 Waters Corporation 11

Intuitive Touchscreen
Pre-Run Checks

©2023 Waters Corporation 12

Intuitive Touchscreen
Run-Time Checks

©2023 Waters Corporation 13

Intuitive Touchscreen
Plots

©2023 Waters Corporation 14

Intuitive Touchscreen
Guided Maintenance

©2023 Waters Corporation 15

Intuitive Touchscreen
Running

©2023 Waters Corporation 16

Intuitive Touchscreen
Error Alerts

©2023 Waters Corporation 17

Intuitive Touchscreen
Bringing Information to the User

©2023 Waters Corporation 18

Customer Support Journey
Bringing Information to the User

1 Analyst uses their 2 After they scan the

mobile device to code, customer is
scan the QR code taken directly to the
on the instrument article on Waters.com
touchscreen
that explains how to
replace the needle

©2023 Waters Corporation 19

eConnect™ Column Tracking Technology
Second Generation Smart Columns Meeting the Specific Needs of the
Compliant Laboratory

Benefits Unlocked with eConnect

HPLC Columns
▪ Automatic column verification
reduces common errors and risk of
reanalysis
▪ Column-use tracking and history
facilitates replacement decisions and
root-cause investigations
▪ Digital platform provides path to
eliminating manual logbooks

©2023 Waters Corporation 20

Made for Empower Software

©2023 Waters Corporation 21

 BACKUP AND ARCHIVE DATA
Secure chromatographic data with automated
GLOBAL REACH disaster recovery backup and centralized data
archive.
No more backing up
Empower Software is the universal
individual workstations
language of the lab and can be found
to discs or drives.
in the farthest reaches of the globe –
in the lab and in the cloud. Backup and archive
from a single database
CONFIDENCE IN QUALITY DATA on the Empower server.

The whole story of

your data is traceable
– from raw data, to
meta data and test IMPROVE DATA INTEGRITY
MAXIMIZE EFFICIENCY results – ensuring the
utmost integrity for Increase compliance with electronic document and
Improve laboratory productivity with enhanced
your data. GxP regulations.
communication and system availability. Restricted
Qualification can be access to data.
Methods, reports, and calculations executed remotely.
remain consistent across all sites
and time stamps are consistent on all
Standardize user privileges and
reports across sites. Proven data longevity restrictions.
with the ability to
Remote access from migrate data since
desk/mobile devices 1992. Data all in one place – for faster,
simpler, confident, and stress-free audits.

©2023 Waters Corporation 22

 Method Matching
Column Tracking & History
Pre-run Checks
Empower System Audit Trail
Touchscreen Interactivity

Your new ally is made for Empower Software.

©2023 Waters Corporation 23

waters_connect System Monitoring
System Monitoring Complements the Alliance iS HPLC System with Holistic Lab
Efficiency Gains
System Monitoring

▪ System Monitoring provides the pulse for the

Empower Software controlled chromatography
lab

▪ Real-time status of Alliance iS HPLC Systems

and all other chromatography systems
controlled by Empower Software

▪ Cloud solution enabling secure insight to lab

status from anywhere, anytime

©2023 Waters Corporation 24

waters_connect System Monitoring
Always-on Cloud Solution Driving Efficiency in Chromatography Laboratories
using Empower Software

Daily Work
Real-Time Status
Coordination

Secure, Remote
Error Access
Notifications

Vendor Agnostic

Asset History
Version &
Instance Agnostic

System Views per Team /

Troubleshooting Lab

©2023 Waters Corporation 25

But That’s Not All…

The Alliance iS HPLC System is packed

with intuitive innovation, including tool-
free, finger-tight fittings

And is built to perform,

time after time

©2023 Waters Corporation 26

Improved Design,
Same Results

©2023 Waters Corporation 27

Alliance iS HPLC System Characteristics

Column Heater/Cooler
TUV Detection
▪ Single column up to 300mm length &
▪ UV/Vis, 190 - 700nm 8mm ID
▪ Reduced detector thermal sensitivity ▪ Accommodates guard column with
300mm column
▪ eConnect HPLC Columns
Sample Management
▪ Flow-through needle design
▪ 3 plates/trays, 54 vial plate option
▪ Self-identifying sample plates with
barcode reader Solvent Management
▪ Quaternary pump
▪ Passive check valves
▪ Optional mixers
▪ Self-priming (peristaltic) seal
Max Pressure: 10,000 psi wash pump
Flow rate range: 0 - 10 mL/min

©2023 Waters Corporation 28

Alliance iS HPLC System: Key Features
Unique Features with the Same or Improved Results Compared to Legacy
HPLC Systems

Alliance iS HPLC System features:

– Outer puncture needle for improved robustness
– Optimized needle wash design to reduce carryover, eliminates
need for analyst to alter settings
– New check valve design for robust performance
– 4-90 deg C temperature range in a single column heater
– Tool-free fitting for common touchpoints

Improved performance:
– Lower carryover specification
– Improved injection precision
– Improved detector sensitivity, thermally controlled

©2023 Waters Corporation 29

Method Migration and Alliance iS HPLC System
Method Migration from Other Systems to Alliance iS HPLC System

Intelligent Method Translator App (iMTA)

– Allows users to translate or move key settings from an ACQUITY™ Arc™ System,
Arc HPLC System, Alliance System or other system instrument method using
Empower Software into an Alliance iS HPLC System method

Expanded performance range

– Upper flow rate range matches legacy HPLC systems (10 mL/min)
– Column temperature range expanded (4 to 90 deg C)
– Easily installed passive preheater is standard, ensuring well-controlled temperature
– Tool-free fittings compatible with range of column hardware

Dwell volume of system can be recorded in touchscreen

– Optional mixers available

Gradient at injection adjustments still available with Gradient SmartStart!

©2023 Waters Corporation 30

Alliance iS HPLC System
Key Features for Method Migration or Method Transfer

Injection Improved Improved

Low Dispersion
Precision Carryover Sensitivity

Dwell
Normal Phase Reliable Check Method
Volume/Optional
Compatibility Valves Translator App
Mixers

©2023 Waters Corporation 31

Intelligent Method Translator App (iMTA)
 Accessible in Empower CDS through
Apps menu in project

 App workflow:
– Select method to translate
– Translate method
– Save Alliance iS HPLC System method 2 1
– Open up translated method in Empower
CDS 3

 Customizable: ability to select specific

modules
 Traceable: generated report stored in
project folder for compliance

©2023 Waters Corporation 32

iMTA Delivers Translated Method

Gradient
table
conversion

 Methods that can be translated include:

– Alliance e2695 System
– Arc HPLC/ACQUITY Arc Systems
– Select systems from other manufacturers

©2023 Waters Corporation 33

Long Term Repeatability

2-Acetylfuran
0.012
0.034
Overlay of 42 injections 0.011

0.032 0.010

0.030 over 44 hours 0.009

0.008

0.007
0.028

AU
0.006
0.026 0.005

0.004
0.024
0.003

0.022 0.002

0.001
0.020
0.000

0.018 20.40 20.60 20.80 21.00 21.20 21.40 21.60 21.80 22.00 22.20 22.40 22.60 22.80 23.00 23.20 23.40 23.60 23.80 24.00 24.20 24.40 24.60 24.80 25.00
AU

Minutes

0.016
Retention Time %RSD
0.014
1 2-Acetylfuran 0.34
0.012
2 Acetanilide 0.17
0.010
Butylparaben
Acetophenone

Valerophenone
Benzophenone
0.008 3 Acetophenone 0.07
Acetanilide

0.006 4 Butylparaben 0.04

0.004 5 Benzophenone 0.04

0.002
6 Valerophenone 0.04
0.000

-0.002
0.00 2.00 4.00 6.00 8.00 10.00 12.00 14.00 16.00 18.00 20.00 22.00 24.00 26.00 28.00 30.00 32.00 34.00 36.00 38.00 40.00 42.00 44.00 46.00 48.00 50.00 52.00 54.00 56.00 58.00 60.00
Minutes

 Overlay of 42 injections of gradient performance mix over 44 hours demonstrates RT repeatability of

< 0.5% RSD on Alliance iS HPLC System.
©2023 Waters Corporation 34
Absorptive Carryover
Wash Settings Optimized for Best Performance
Chlorhexidine Carryover - Multiple Wash Modes Alliance iS HPLC System Carryover
0,1
0.0036
0.0036

0,08 Challenge (1.14 mg/mL)

Standard (11.4 µg/mL)
% Carryover

0.0030
0.0030
0,06 Post blank 1

0.0024
0.0024
0,04

AU
AU
0,02 0.0018
0.0018

0 0.0012
0.0012

default with default with default wash wash default wash wash default
wash wash mode 2 mode 3 mode 2 mode 3
0.0006
0.0006
HPLC 1 HPLC 2 HPLC 3 HPLC 4 Alliance
12.40
12.40 12.80
12.80 13.20
13.20 13.60
13.60 14.00
14.00 14.40
14.40
iS HPLC Minutes
Minutes

System

 For HPLC systems 1 – 3, the default or recommended wash is No Wash

 The Alliance iS HPLC System showed the lowest overall carryover of the systems tested, with only 0.00055% carryover
 Application Note: “Improved Chlorhexidine Carryover Performance Using the Alliance iS HPLC System,” Jennifer Simeone,
Paula Hong
©2023 Waters Corporation 35
Superior Injection Precision for Wide Range of Applications
Quetiapine Fumarate Organic Ibuprofen Organic Impurities Standard
Impurities Standard (1 μg/mL)

Sys Suit -NMT 5% Sys Suit -NMT 6%

0,4 3,5 0,35

0,35 3 0,3
0,3 2,5 0,25

%RSD

%RSD
0,25 2 0,2
%RSD

0,2 1,5 0,15

0,15 1 0,1
0,1 0,5 0,05
0,05 0
0
Ibuprofen Area RSD
0 RC J Area RSD RC C Area RSD
Quetiapine standard
%RSD Area Alliance iS HPLC System Alliance iS HPLC System
Alliance iS HPLC System HPLC System 1 HPLC System 1
HPLC System 1
HPLC System 3 HPLC System 3
HPLC System 2

 Conditions and analyses based on current USP monograph

 Alliance iS HPLC Systems showed improved precision values (lowest %RSD) across systems tested
 Application note: “Method Migration of the USP Ibuprofen Assay and Organic Impurities Method to an Alliance iS HPLC
System,” Corey Reed, Paula Hong
©2023 Waters Corporation 36
Same Results on Alliance iS HPLC System
USP Monograph for Quetiapine Fumarate Organic Impurities
0.020
API USP
Alliance System Agilent 1100 Alliance iS
0.015 Alliance Acceptance
Quat HPLC System
0.010
Criteria
AU

0.005 Quetiapine desethoxy Unknown impurity Quetiapine

desethoxy 0.10 0.11 0.10 NMT 0.15
0.000
(%)
-0.005

0.020
Unknown
0.015
Agilent 1100 Impurity (%) 0.07 0.07 0.07 NMT 0.15
Quaternary
0.010
System Total
AU

0.005 Impurity (%) 0.17 0.18 0.17 NMT 0.50

0.000

-0.005

0.020

0.015
Alliance iS HPLC System
0.010
AU

0.005

0.000

-0.005

26.00 27.00 28.00 29.00 30.00 31.00 32.00 33.00 34.00 35.00 36.00 37.00 38.00 39.00 40.00 41.00
Minutes

 Analysis of quetiapine fumarate drug substance shows comparable results to select HPLC systems
 Analyses performed using independent sample preparation

©2023 Waters Corporation 37

High Performance for Challenging HILIC Methods
Alliance iS HPLC
HPLC System 1 HPLC System 2
System

Area %RSD (NMT 2.0) Standard Solution 0.748 0.501 0.315

Retention Time %RSD (NMT 2.0) Standard Solution 0.017 0.030 0.032

USP Tailing (NMT 2.0) System Suitability Solution1 0.981 1.205 0.950

USP Resolution (HH) (NLT 2.0) Sys Suit Solution2 2.842 2.569 3.151

USP Resolution (NLT 2.0) Sys Suit Solution 2.784 2.517 3.092

USP Signal to Noise (NLT 10) Sensitivity Solution 21.32 (74.48+) 30.53 90.27

Alliance iS HPLC System  USP Monograph for Cetirizine

0.010
Organic Impurities
Cetirizine RC A
AU

Mobile phase: 93%  Alliance iS HPLC System shows

0.005 Cetirizine
acetonitrile/ 6.6% water/
0.4 % sulfuric acid best performance in signal-to-
0.000 noise and resolution as compared
to other HPLC systems
4.00 4.20 4.40 4.60 4.80 5.00 5.20 5.40 5.60 5.80 6.00 6.20 6.40 6.60 6.80 7.00 7.20 7.40 7.60
Minutes

1 - Tailing calculated off Cetirizine HCl peak, 2 - Resolution between Cetirizine Related Compound A and Cetirizine HCl, + - Calculated from segment on baseline
and not a blank. Carryover in Blank

©2023 Waters Corporation 38

Ability to Run Normal Phase Chromatography
0.90

Mobile phase: 95% hexane, 5% ethyl

0.80
acetate, 0.5% acetic acid
0.70

0.60

0.50
AU

0.40

0.30

0.20

0.10
tocopherols
n=6
0.00

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00 7.50 8.00 8.50 9.00 9.50 10.00
Minutes

 Alliance iS HPLC System is compatible with normal phase mobile phases

 Normal phase kit includes replacement check valves and outlet/waste lines

©2023 Waters Corporation 39

Scaling Methods on a Single System
System Compatible with Wide Range of Columns
Monograph Symmetry™ C18 Column, 3.9 x 150 mm, 5 µm, 100Å
L/dp-30,000

SST passes for

all columns
USP Resolution
Symmetry C18 Column, 4.6 x 150 mm, 5 µm, 100Å
NLT 1.5 Abacvir
L/dp-30,000
Trans-Abacvir

Symmetry C18 Column, 4.6 x 100 mm, 3.5 µm, 100Å

L/dp- 29,000

 Alliance iS HPLC System can accommodate a wide range of columns, meeting system suitability criteria
 With higher pressure capability vs legacy systems, Alliance iS HPLC System (10,000 psi) allows for scaling to a wider range of columns
 Application Note: “Achieving Method Modernization with the New Liquid Chromatographic Gradient Method Allowances Provided by
General Chapter, USP Chromatography <621> and the Alliance iS HPLC System”, Catharine E. Layton, Paul D. Rainville
©2023 Waters Corporation 40
Summary: Alliance iS HPLC System Chromatographic
Performance
 Alliance iS HPLC System – designed with the user in mind with improved
performance over many legacy systems
– Designed to reduce user error and providing confidence in chromatographic performance

 Method Translator App allows for translating instrument methods to an Alliance iS

HPLC System instrument method, all within Empower Software

 The Alliance iS HPLC System can meet system suitability for a range of challenging
methods
– Improved performance (precision, resolution, carryover) compared to legacy systems.

©2023 Waters Corporation 41

Waters Liquid Chromatography System Portfolio

Confidently Make Critical Decisions

LC measurements provide accurate analytical information to make
profound discoveries, optimize operations, deliver safe products, and
ensure regulatory compliance.

Dependability Flexibility Performance Specialty Purification

3.5-5μm 2.5 - 5μm Sub 2.0μm

High-performance
Essential technology
Flexible, technology delivered in Focused, comprehensive Scalable configurations from
compatible technology at all optimized configurations that system solutions to meet lab-scale to bulk providing the
delivered in limited
performance levels to enable simplicity of automated
configurations to enable
method development,
maximize the application- systems and the specificity of
highly-reliable, low-complexity
routine analyses
facilitate method transfer and sensitivity , specific mass-directed
streamline routine
deployment
reproducibility and workflow requirements. purification
robustness

The Alliance iS is designed to be the most advanced, user friendly HPLC system
©2023 Waters Corporation 42
Thank You

©2023 Waters Corporation 43