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©2015 Waters Corporation 1
Introducing the Newest Member of the Waters
LC Portfolio
ACQUITY ArcTM System
©2015 Waters Corporation 2
Highly competitive, regulated business environment – Need to lower costs without compromising product quality while maintaining
regulatory and compliance requirements – Decrease time to market while maintaining quality of information
Challenged to increase profitability
– Increasing regulatory pressures, price controls, increased quality expectations, and competitive pressures
– Pressure to reduce manufacturing costs – Harmonize approach across sites
o Simplify method transfer o Manage diversity of available platforms
Deliver sustainable competitive advantage
– Invest in the correct technologies to achieve business objectives – Capacity to grow the business and anticipate that need – Demonstrate fast return on investment
Adopting Modern LC Technology in a Global Economy
©2015 Waters Corporation 3
What System is right for my Laboratory?
©2015 Waters Corporation 4
LC Separations Categories
How are these categories differentiated?
Chromatographic Resolution Increases
Overall Run Time Decreases
Method Sensitivity Increases
©2015 Waters Corporation 5
Defining the LC Categories: Power Range vs. Dispersion
LC systems trying to cover a wide “power range” (flow rate / pressure envelope) end up compromising extra-column dispersion, and therefore performance, in efforts to accommodate both sub 2 µm and traditional column technologies.
Flow rate range and available pressure alone have little bearing on the actual separation power of the system and do not provide an appropriate measurement of system performance.
Define the difference between UHPLC and UPLC
mAU
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400.00
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Rs = 0.52
Rs = 1.53
Rs = 1.44
Rs = 2.84
1290 UHPLC with Higher
‘Power Range’
ACQUITY UPLC H-Class with Lower
‘Power Range’
True separation performance is governed by system dispersion
©2015 Waters Corporation 6
What is at the Root of the Performance Differences across the LC Categories?
Dispersion – n. Broadening of an analyte band due to both on-column effects (diffusion and mass transfer kinetics which are both dependent on particle size and linear velocity) and system effects (tubing internal diameter (I.D.) and length, connections, detector flow cell volumes, etc.)
True separation performance is governed by the system dispersion paired with a flow rate range that yields the highest possible efficiency for a given analytical column
©2015 Waters Corporation 7
Defining the LC Categories
Dispersion > 30 µL Columns accepted:
• 3.0 – 4.6 mm ID • 3 - 10 µm particles
Optimal:
• 4.6 mm ID, 5 µm
Typical operating pressure: • < 6,000 PSI
Dispersion 12 - 30 µL Columns accepted:
• 2.1 - 4.6 mm ID • 1.7 - 5 µm particles
Optimal:
• 3.0 mm ID, 2.x µm
Typical operating pressure: • 6,000 – 15,000 PSI
Dispersion < 12 µL Columns accepted:
• 1.0 - 4.6 mm ID • 1.6 - 5 µm particles
Optimal column:
• 2.1 mm ID, 1.7 µm
Typical operating pressure: • 9,000 – 15,000 PSI
Increased flexibility and sample characterization
©2015 Waters Corporation 8
Dispersion Impact on Performance: Gradient Separations on UHPLC and UPLC
Column: C18 2.1x 50 mm USP Assay for Diclazuril
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UHPLC Extra column dispersion 25 µL
UPLC Extra column dispersion< 10 µL
1
2 3
4 5 6 USP Res= 1.5
USP Res= 2.0 USP Res= 2.7
USP Res= 1.8
No Compound
1 6 carboxylic acid
2 6-carboxamide
3 Diclazuril
4 Ketone
5 4-amino Derivative
6 Des-cyano derivative
©2015 Waters Corporation 9
Dispersion Impact on Performance: Isocratic Separations on HPLC, UHPLC and UPLC
UHPLC UPLC HPLC A
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* Strong solvent effects
*
*
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x 5
0 m
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.6 µ
m
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x 7
5 m
m,
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.7 µ
m
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x 7
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m,
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.7 µ
m
©2015 Waters Corporation 10
Dispersion Impact on Performance: Isocratic Separations on HPLC, UHPLC and UPLC
UHPLC UPLC HPLC A
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* Strong solvent effects
*
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0 m
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.6 µ
m
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x 7
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.7 µ
m
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.7 µ
m
©2015 Waters Corporation 11
Init
ial C
apit
al C
ost
Product Lifecycle HPLC
UHPLC
LOW
HIGH
Total Cost of O
wn
ership
LOW
HIGH
UPLC
HPLC
UHPLC
UPLC
Business Impact of Method Improvements: ROI and TCO
©2015 Waters Corporation 12
Business Impact of Method Improvements
Cost / Sample Solvent Usage / Year Cost / Year / Assay
ACQUITY Arc System using a 5 µm HPLC column (Run Time = 45 min)
$12.33 USD 544 Liters $54,432 USD
ACQUITY Arc System using a 2.x µm UHPLC column (Run Time = 11 min)
$2.60 USD 156 Liters $15,562 USD
SAVINGS with UHPLC $9.73 USD 388 Liters $38,870 USD
ACQUITY UPLC H-Class with a 1.7 µm UPLC Column (Run Time = 5 min)
$0.79 USD 78 Liters $7,776 USD
SAVINGS with UPLC $11.54 USD 466 Liters $46,656 USD
©2015 Waters Corporation 13
Implementing Modern LC Technology into Routine Analysis Laboratories
Newer LC technologies first adopted in earlier stages of the product development lifecycle (i.e., Drug Discovery, Early Development)
Adoption into routine analysis laboratories occurs only after the receipt of methods from earlier stages of the product lifecycle
Technology must be repeatable, robust and reliable – Minimize failure, OOS, repeat analyses
Versatile LC platform that must maintain compliance with
established, validated methods
Must maintain compatibility with existing informatics platform
©2015 Waters Corporation 14
Bridging-the-Gap Between HPLC and UPLC Technology
HPLC UPLC UHPLC
Extends the ACQUITY family into laboratories requiring method compatibility with HPLC and
UHPLC (2.x µm) separations
©2015 Waters Corporation 15
The ACQUITY ArcTM System
Versatility without Compromise – Replicate established HPLC assays
without compromise o System-to-system transfer o “Method Transfer”
– Improve productivity with modern UHPLC
column technology o 2.x µm fully porous and solid core technology o “Method Improvement”
– Accept method adjustments from earlier
stages in the product development process o Sub-2-µm adjusted up to 3 – 5 µm for routine
analysis o “Method Adjustment”
©2015 Waters Corporation 16
3.13
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3
8.18
6
10.3
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0.08
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Replicate Your Established Methods: ArcTM Multi-Flow Path Technology
Agilent LC System
ACQUITY Arc System
Gradient table, flow rate, column temperature were maintained on all instruments Conditions: 5 to 60% MeOH over 15 minutes; Mobile phase A: 0.1% HCOOH in H2O, Mobile phase B: 0.1% HCOOH in MeOH; Flow rate = 2.9 mL/min; Column: XSelect CSH C18 4.6 x 150mm, 5 µm; Temp = 45 oC; UV @ 270 nm; 10.0 µL Inj. Vol.
©2015 Waters Corporation 17
ACQUITY ArcTM System: Replicate. Improve. Adjust.
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1 2 3
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ACQUITY Arc System XBridge C18 5 µm 4.6 x 150 mm Flow Rate = 1.0 mL/min Inj. Vol. = 10.0 µL
ACQUITY Arc System XBridge C18 2.5 µm 3.0 x 75 mm XP Flow Rate = 0.85 mL/min Inj. Vol. = 2.1 µL
ACQUITY UPLC H-Class System ACQUITY UPLC BEH C18 1.7 µm 2.1 x 50 mm Flow Rate = 0.61 mL/min Inj. Vol. = 0.7 µL
The ACQUITY Arc System enables support HPLC and UHPLC methods on a single platform.50 to 80% MeOH; Temp = 40 oC; UV @ 254 nm; (1) prednisone, (2) hydrocortisone, (3) dexamethazone, (4) estradiol, (5) 17α – hydroxyprogesterone, (6) levonorgestrel, (7) progesterone
Ad
just
Imp
rove
1.80 min
3.60 min
15.00 min
©2015 Waters Corporation 18
The ACQUITY Arc System: Bridging the Performance Gap
The ACQUITY Arc System is intended to bridge-the-gap between HPLC and UPLC Technology. – Transitioning methods to UPLC will still provide the largest business and
scientific benefits
However, we do recognize and acknowledge that for many organizations, that transition is a journey and not an immediate conversion. – For many organizations, there is an intermediate step that must first take
place to transfer their established methods, as is, to a modern LC platform.
With the introduction of the ACQUITY Arc System, analytical scientists can experience method compatibility for HPLC and UHPLC (2.x µm) separations. – A single LC platform that allows the efficient transfer, adjustment, or
improvement of methods from any LC platform without compromise.
©2015 Waters Corporation 19
Thermal management options 30-cm Column Heater and Column Heater/Cooler options provide stable, uniform temperature management to ensure method repeatability from lab to lab. Integrated column selection valve options provide unattended, fast column change over
Auto●Blend Plus Technology Program gradients directly in terms of pH and % organic to minimize manual mobile phase preparation, reduce human error and accelerate method robustness testing for reversed-phase or Ion-Exchange chromatographic methods
ArcTM Multi-Flow Path Technology Delivers plug-and-play method compatibility with HPLC or UHPLC methods at the flip of a switch. Easily replicate or improve established methods by simply selecting between Path 1 (HPLC) or Path 2 (UHPLC) without any manual user intervention
Gradient SmartStart Automatically manage gradient start time and pre-injection steps in parallel, to minimize cycle time and maximize sample throughput. Automatically counteract differences in system dwell volume without the need to alter gradient table inputs.
Quaternary Solvent Management Precise and accurate blending of up to four solvents with automated solvent compressibility compensation at pressures up to 9,500 PSI (655 bar) up to 5 mL/min Increase solvent flexibility with an optional, integrated solvent select valve, providing access to 6 additional solvents.
Negligible Carryover Advanced flow-through-needle design minimizes carryover by continuously cleansing the needle during the run, providing carryover of < 0.002%. User settable wash settings provide flexibility to address even the most complex sample matrices.
Comprehensive Detector Portfolio High performance analytical detectors designed to maximize HPLC and UHPLC performance to deliver exceptional sensitivity and linearity for your assays. Photodiode Array, UV/Vis, Fluorescence, Refractive Index, Evaporative Light Scattering and Mass Detection
©2015 Waters Corporation 20
ACQUITY Arc System: Quaternary Solvent Manager-R
Pressure transducers
Gradient proportioning valve Solvent degasser
Passive check valves
ArcTM Multi-flow path technology
Seal wash pump
Optional solvent select valve
©2015 Waters Corporation 21
Arc Multi-flow pathTM Technology
©2015 Waters Corporation 22
Addressing Method Transfer Challenges: Emulating System Behavior
Challenges for system-to-system method transfer – Matching gradients requires matching of dwell volume and mixing behavior – Matching the thermal environment of the column both oven temperature and
inlet preheating must be preserved. – Extra column dispersion must be equal to, or better than, the origin system
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UPLC trace
Programmed gradient
HPLC trace
Gradientdelay UPLC
Gradient delay HPLC
Equilibration
©2015 Waters Corporation 23
Addressing Method Transfer Challenges: Emulating System Behavior
Why is Plug-and-Play Methods Transfer Necessary? – USP <621> says about gradient methods …” If adjustments are necessary,
only column changes (same packing material) or dwell volume adjustments are recommended.”
– Changes to gradient methods are perceived as being risky and are poorly understood.
How Can HPLC Fluidics Be Emulated? Match key fluidic characteristics – match dwell volume and mixing behavior
without changing gradient table
Model and simulate fluid behavior (Arc Multi-flow pathTM technology)
Adjust gradient table to account for differences in mixing behavior and dwell volume (not desirable)
©2015 Waters Corporation 24
Arc Multi-Flow Path Technology
Path 1 Gradient Delay Volume = 1100μL Path 2 Gradient Delay Volume = 700μL
Larger mixing volume ‘disperses’ the edges of the gradient making it more ‘HPLC-like’
©2015 Waters Corporation 25
System Emulation with Arc Multi-Flow Path Technology and Gradient SmartStart
Arc Multi-flow pathTM technology
Select Path 1 or Path 2
Gradient SmartStart
Selectable dwell volume that emulates both system volume and mixing behavior
Adjust when the gradient starts relative to the injection sequence – Compensates for transferring
methods from LC systems with variable volume
Does not impact the gradient table
– Falls within USP <621> guidelines on transferring gradient methods between different chromatographic systems
©2015 Waters Corporation 26
Gradient SmartStart
Gradient SmartStart Offset = 100μL
Original HPLC System has 1200μL Gradient Delay Volume
Path 1 Gradient Delay Volume = 1100μL
Total Gradient Delay on ACQUITY Arc = 1200μL
©2015 Waters Corporation 27
Replicate Your Established Methods: Arc Multi-Flow PathTM Technology
Chromatographic data of the metoclopramide API at 0.5 mg/mL with 1.0% of related substances for the method transfer from an Agilent LC System to an ACQUITY Arc System.
No. Analyte1 Impurity F2 Metoclopramide3 Impurity A4 Impurity G5 Impurity 96 Impurity H7 Impurity C8 Impurity D9 Impurity B
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Agilent 1260 Infinity LC System
ACQUITY Arc System
1 3 4
2
56
7
8
9
13
4
2
5 67
8
9
Agilent LC System
ACQUITY Arc LC System
©2015 Waters Corporation 28
Streamline Your Workflow with Auto-Blend Plus Technology
Routine analysis: System prepares buffers at desired pH and ionic strength
Method validation: Powerful tool for automating testing method robustness
Method development: Avoid manual titration of eluents to prepare buffers at a fixed pH
Minutes 3.00 4.00 5.00 6.00 7.00
pH 2.95
pH 3.75
©2015 Waters Corporation 29
Sample Manager FTN-R Injection valve with 50 µL loop
Metering syringe
Plate toggle switch
2x Sample Tray
©2015 Waters Corporation 30
Sample Manager FTN-R: Injector Linearity
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0.2 – 5.0 µL
5.0 – 50.0 µL
Linearity for injection volumes of: 0.2 to 5.0 uL Values are R^2 linear correlations (1.00 is ideal) X intercept values are in nL (smaller is better and closer to origin)
Trial R^2 X Intercept
1 0.999973 -19.42
2 0.999899 -15.05
3 0.999964 -33.02
Average 0.999945 -22.50
Linearity for injection volumes of: 5.0 to 50.0 uL Values are R^2 linear correlations (1.00 is ideal) X intercept values are in nL (smaller is better and closer to origin)
Trial R^2 X Intercept
1 0.999987 1.01
2 0.999987 1.01
3 0.999995 0.90
Average 0.999990 0.97
©2015 Waters Corporation 31
Sample Manager FTN-R: Exceptional Carryover Performance
5.0 mg/mL Challenge sample
0.002% reference standard
Post challenge blank No detectable carryover
©2015 Waters Corporation 32
Column Heating Options CH30-A new 0.005” active preheater (up to 90 oC)
30-cm CH and CHC new low dispersion passive preheater (up to 65 oC) Optional 3-position column select valve
©2015 Waters Corporation 33
High Performance Detection Options
2998 PDA New Low dispersion analytical flow cell
2489 UV/Vis New Low dispersion analytical flow cell
2414 RI
2475 FLR New Low dispersion analytical flow cell
2424 ELS
ACQUITY QDa
New ICS that enables Waters Console control!
©2015 Waters Corporation 34
ACQUITY QDa Mass Detector: For all Scientists, Samples and Separations
©2015 Waters Corporation 35
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Imp. F
Apex
213.5 272.8 311.0
286.1
288.1
API
Apex
213.5 272.8 309.1
300.1
302.0
Imp. A
Apex
212.9 263.0 306.0
342.0
343.9
Imp. G
Apex
211.0 271.5 307.9
316.0
317.9
UV Spectra
MS Spectra
286.
1 –
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1 -
API
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0 –
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9
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224.
1 –
Imp.
D
258.
0 –
Imp.
B
ACQUITY Arc System
Improved Sample Characterization with ACQUITY QDa Mass Detection
©2015 Waters Corporation 36
The ACQUITY ArcTM System
Versatility without Compromise – Replicate established HPLC assays
without compromise o System-to-system transfer o “Method Transfer”
– Improve productivity with modern UHPLC
column technology o 2.x µm fully porous and solid core technology o “Method Improvement”
– Accept method adjustments from earlier
stages in the product development process o Sub-2-µm adjusted up to 3 – 5 µm for routine
analysis o “Method Adjustment”
©2015 Waters Corporation 37
Replicate. Improve. Accept.
©2015 Waters Corporation 38
Appendix
©2015 Waters Corporation 39
ACQUITY ArcTM System
Comprehensive Detection Portfolio • 2998 PDA, 2489 UV/Vis, 2414 RI, 2475 FLR, 2424 ELS • ACQUITY QDa Mass Detector
Thermal Management Options •30cm column heater; column heater /cooler (up to 65 oC) •30cm column heater with active pre-heating and eCord capability (up to 90 oC)
Sample Manager FTN-R • Injection volume up to 1000 µL • Auto-addition and dilution • Optional sample compartment cooling 4 to 40 oC
Quaternary Solvent Manager-R • 9,500 PSI to 5 mL/min • Auto-Blend Plus Technology • Arc Multi-flow pathTM technology (selectable
dwell volume)
System performance • 25 µL system dispersion (Alliance = 34 µL, H-Class = 7 µL) • Ideally suited 3.0 / 4.6 mm ID columns 2.5 – 10 µm
©2015 Waters Corporation 40
Specification Comparison: Total System and Solvent Manager
Specification / Feature ACQUITY Arc Agilent Infinity 1260 Quaternary SL
Shimadzu Nexera-i
Total system dwell volume Path 1 = 1100 µLPath 2 = 700 µL
800 to 1100 µL 460 µL
System dispersion (band spread)
25 µL 25 µL TBD
Flow rate range 0.001 to 5.000 mL/min 0.001 to 10.0 mL/min 0.0001 to 10 mL/min
Maximum operating pressure 9,500 PSI (655 bar) up to 5 mL/min
8700 PSI (600 bar) up to 5 mL/min2950 PSI (200 bar) from 5 to 10 mL/min
9572 PSI (660 bar) up to 3 mL/min6381 PSI (440 bar) from 3 to 5 mL/min3190 PSI (220 bar) from 5 to 10 mL/min
Compositional accuracy +/- 0.5% absolute from 5 to 95%
Not stated +/- 0.5% (0.01 to 2 mL/min)
Compositional precision < 0.15% RSD or +/- 0.04 minSD (whichever is greater)
< 0.2% RSD or < 0.04 min SD (whichever is greater)
+/- 0.1% RSD
Number of solvents One to four; optional solvent select valve (D1-6)
One to four One to four
Flow precision < 0.075% RSD or < 0.020 min SD (whichever is greater)
< 0.07% RSD or < 0.020 min SD (whichever is greater)
< 0.06% RSD or < 0.020 min SD (whichever is greater)
Flow Accuracy +/- 1% at 0.5, 3.0 and 5.0 mL/min
+/- 1% or 10 µL/min (whichever is greater)
+/- 1% (0.01-2 mL/min)
©2015 Waters Corporation 41
Specification Comparison: Sample Manager FTN-R
Specification / Feature ACQUITY Arc Agilent Infinity 1260 Quaternary SL
Shimadzu Nexera-i
Injection volume range 0.1 – 50 µL standard; up to 1000 µL (optional)
0.1 – 100 µL standard; up to 1500 µL (optional)
0.1 – 50 µL standard; up to 2000 µL (optional)
Injector precision <1.0% RSD 0.5 to 1.0 µL<0.5% RSD 1.0 to 5.0 µL<0.25% RSD 5.0 to 1000 µL
<1.0% RSD 1.0 to 5.0 µL<0.25% RSD 5 to 100 µL
<1.0% RSD 0.5 to 0.9 µL<0.5% RSD 1.0 to 1.9 µL<0.25% RSD 2.0 to 4.9 µL<0.20% RSD 5.0 to 2000 µL
Injector accuracy +/- 0.2 µL Not specif ied +/- 1%
Injector linearity >0.999; 0.5 to 50.0 µL Not specif ied >0.9999 1.0 to 100 µL
Sample carryover < 0.002% caffeine (UV) <0.1%, < 0.05% with external needle wash
< 0.0025% caffeine (UV)
Sample capacity (Default) 96 vials (2 mL);2 x 96 well plates;2 x 384 well plates
100 vials (2 mL) 112 vials (4 mL);216Vials (1.5 mL);336 vials (1 mL)
Temperature Control 4 – 40 oC (optional) 10 oC below ambient to 80 oC 4 – 45 oC