DEVELOP. VALIDATE. TRANSFER.

Transcription

1 [ ACQUITY UPLC Column Strategies ] ULTRA PERFRMANCE DEVELP. VALIDATE. TRANSFER.

2 UPLC particle technology The ACQUITY UPLC column family continues to evolve and expand, now including three particle substrates [BEH 0Å, BEH 00Å and HSS] and chemistries, all of which are scalable between HPLC and UPLC particle sizes. With a number of selectivity choices for both small molecule and biopharmaceutical applications, Waters has a UPLC column solution to meet your application needs.. µm. µm.,.0 µm BEH C.,.,.0, 0.0 µm BEH 00Å C Si BEH C Si BEH Shield RP Si BEH 00Å C CH HSS T Polar Group CH BEH Phenyl HSS C Si BEH HILIC BEH Amide HSS C SB Si Linker NH Si CH Si CH Si Si Si

3 Discover how to overcome your analytical challenges with the ACQUITY UPLC H-Class System

4 Transfer between LC technology platforms with ease More and more organizations have realized the benefits of improved productivity, higher data quality, and lower cost per sample as well as faster time-to-market, inherent in assays that utilize UPLC Technology. The ACQUITY UPLC H-Class System is a result of this paradigm shift, enabling the efficacy of a method to be preserved as it is transferred between LC platforms. UPLC Separation on ACQUITY UPLC H-Class System ACQUITY UPLC BEH Shield RP. x 0 mm,. µm In addition to the proper geometric scaling of all method parameters, the successful transfer of an analytical method requires the preservation of chromatographic column selectivity and resolving power, regardless of particle size. Waters industry leading manufacturing processes not only ensures unprecedented batch-to-batch reproducibility, but also sustained selectivity between HPLC and UPLC particle sizes. New Method Transfer kits leverage this capability, enabling the successful transfer of methods from one LC platform to another. C B A D..0.. HPLC Separation on Alliance HPLC System XBridge Shield RP. x 00 mm,. µm min D C A B 0 min HPLC Separation on ACQUITY UPLC H-Class System Method Transfer Kit XBridge Shield RP. x 00 mm,. µm Each kit contains one UPLC column, one HPLC column and an ACQUITY UPLC Columns Calculator. 0 min A separation of clozapine and its related compounds is used to demonstrate the exceptional scalability between different size chromatographic particles and instrument platforms to facilitate a successful method transfer. Retention Time Relative to Separation Mode Instrument Impurity D Impurity C Impurity A Impurity B UPLC ACQUITY UPLC H-Class System HPLC Alliance 9 System HPLC ACQUITY UPLC H-Class System [ ]

5 Minimize risk with dependable column performance To ensure the continued reliability and reproducibility of an analytical method, it is essential to test and validate with multiple batches of chromatographic media. As a primary manufacturer of silica and hybrid particles, Waters has D C A Batch 9 Base Particle Lot 0 B set the industry benchmark for batch-to-batch reproducibility. With well-established particle and column manufacturing process control, batch-to-batch and column-to-column variability is minimized, providing confidence in long term analytical method reliability. D C A Batch 0 Base Particle Lot B ACQUITY UPLC Method Validation kits provide three batches of chromatographic media [derived from different base particles] to judge the quality, reliability, and consistency of an analytical method. D C A Batch Base Particle Lot 9 B Selectivity (a) Batch Impurity C Impurity A Impurity B min Three different batches of bonded material derived from three different base particles demonstrate the solid reproducibility that can be expected from ACQUITY UPLC columns, assuring the long term reproducibility of your analytical method. Performance-driven reliability Separation scientists can be assured that results achieved today will be repeatable and reproducible year after year. With fully integrated manufacturing and stringent process control, Waters is uniquely positioned as an industry partner to minimize the risk of method variation due to differences caused by chromatographic media batch or column inconsistency. Ligand Density [µmol/m ] ACQUITY UPLC BEH C Coverage Batch UCL LCL Propranolol/acenaphthene [Alpha] Base/Neutral Selectivity Batch UCL LCL Processes control charts for batches of ACQUITY UPLC BEH C demonstrating manufacturing control and long term repeatability between material batches over the course of five years. [ ]

6 Efficient reversed-phase method development strategy Reversed-phase HPLC method development can take anywhere from weeks to months, incurring large operational cost. By utilizing the ACQUITY UPLC H-Class System for method development, a substantial improvement in throughput can be realized. This, in turn, reduces cost per sample and time of analysis considerably while maintaining or improving separation integrity. By developing rapid, highresolution analytical methods, products can be brought to market faster, therefore, improving the overall profitability of the assay. There are a number of approaches to method development, the most common is a systematic screening of chemical factors [combinations of column chemistry, mobile-phase ph, and organic modifier] or a column selection approach [with devoted mobile-phase components]. Waters Method Development kits offer combinations of different column chemistries to accommodate your method development approach, enabling methods to be developed efficiently and effectively. High and Low ph, Widest Selectivities UPLC Columns Kit ph 0/MeH gradient L UPLC Columns Kit ph /ACN gradient BEH C BEH C BEH Shield RP BEH Shield RP, BEH C HSS C BEH Phenyl HSS T..0.. min..0.. min With BEH Technology, robust methods can be developed across an unparalleled range of temperature, mobile-phase ph, and pressures to improve organizational efficiency and bring products to market faster. Compound List With a wide range of UPLC column selectivities available, screening multiple columns with a single mobile-phase condition can quickly lead to a successful result. [] propranolol [] berberine [] -pyrenesulfonic acid [] dimethyl phthalate [] amitriptyline [] diethyl phthalate [] fenoprofen [] dipropyl phthalate [ ]

7 A novel reversed-phase and HILIC method development strategy The retention and quantitation of polar analytes and metabolites continues to be an exceptional chromatographic challenge for analytical scientists. Reversed-phase is the most universally accepted and implemented technique, however, it is not particularly well suited for analytes that are hydrophilic [polar]. Hydrophilic interaction chromatography [HILIC] is a complementary chromatographic technique that can be used to successfully improve the retention of very polar species. However, due to the intricate combination of multiple retention mechanisms, HILIC is also a useful technique for the retention and improved MS response of ionizable species, regardless of their polarity. The new capabilities of the ACQUITY UPLC H-Class System enable the sequential development of methods using a novel reversed-phase and HILIC approach. This innovative approach provides a comprehensive combination of selectivity choices to effortlessly retain and resolve compounds encompassing a broad range of polarity. UPLC RP and HILIC Method Development Scouting Kit Reversed-phase HILIC BEH Amide BEH C BEH Shield RP HSS C SB min Method development for morphine-related compounds using a novel reversed-phase and HILIC approach. Compound List [] -acetylmorphine [] morphine [] morphine-β D-glucuronide [ ]

8 UPLC column kits Take the guesswork out of method transfer New Method Transfer kits are designed to preserve the integrity of a separation as it is transferred between UPLC and HPLC platforms. Based on the concept of maintaining column length [L] to particle size [dp] ratio [L/dp], these kits provide an ACQUITY UPLC column with an HPLC column of equivalent selectivity and resolving power. Using the ACQUITY UPLC columns calculator (included with each kit), methods can be fully transferred from HPLC to UPLC or from UPLC to HPLC. Method Transfer Kit Develop methods with ease With a seemingly endless number of method parameters to try, developing a new chromatographic method can be an overwhelming, and time-consuming experience. Essential to any method development strategy is finding a suitable column that delivers the desired separation while resulting in a robust and reliable separation. Waters Method Development kits consist of several UPLC columns, encompassing a broad range in selectivity, to accommodate your method development approach and enable methods to be developed efficiently and effectively. Package Name Chemistries Method Development Strategy High & Low ph, Widest Selectivities UPLC Columns kit UPLC Method Development Scouting kit L UPLC Columns kit Mass Spec UPLC Columns kit Low ph, Widest Selectivities UPLC Columns kit UPLC RP and HILIC Method Development Scouting kit UPLC HILIC Method Development Scouting kit BEH C, BEH C, BEH Shield RP, BEH Phenyl BEH C, BEH Shield RP, BEH Phenyl, HSS T BEH C, BEH Shield RP, HSS C, HSS T BEH C, HSS C, HSS C SB, HSS T BEH Shield RP, BEH Phenyl, HSS C, HSS C SB BEH C, BEH Shield RP, BEH Amide, HSS C SB BEH Amide, BEH HILIC Maximize separation selectivity by exploring low and high mobile-phase ph. Maximize separation selectivity by exploring low and high mobile-phase ph (BEH columns) and accommodate for the retention of polar compounds (HSS T). C columns that differ in silanol activity and hydrophobicity within the US Pharmacopeia L classification. Straight-chain alkyl C columns that differ in silanol activity, shape, selectivity and hydrophobicity, and exhibit no MS bleed. The most diverse grouping of column selectivities for the development of a reversed-phase method in low ph mobile phases. A novel approach that maximizes separation selectivity by combining distinct RP and HILIC stationary phases to retain analytes encompassing a broad range of polarity. Effortlessly develop HILIC methods at low ph (bases) or high ph (acids) for polar and/or ionizable compounds. Ensure method robustness The reproducibility of the chromatographic column has a critical impact on the long-term reliability and robustness of an analytical method, and its reproducibility lies completely outside the users control. With exceptional batch-to-batch and column-to-column reproducibility, Waters well-established particle and column manufacturing process control provides confidence in the long-term reliability of your analytical method. ACQUITY UPLC Method Validation kits include three batches of chromatographic media [derived from different base particles] to judge the quality, reliability, and consistency of your chromatographic method. [ ]

9 rdering information ACQUITY UPLC Method Development Kits Package Name Qty/Pk Chemistries Particle Size(s) Dimensions Part No. High & Low ph, Widest Selectivities UPLC Columns kit /pk BEH C, BEH C, BEH Shield RP, BEH Phenyl BEH:. µm. x 0 mm 000 High & Low ph, Widest Selectivities UPLC Columns kit /pk BEH C, BEH C, BEH Shield RP, BEH Phenyl BEH:. µm. x 00 mm 000 High & Low ph, Widest Selectivities UPLC Columns kit /pk BEH C, BEH C, BEH Shield RP, BEH Phenyl BEH:. µm.0 x 0 mm 00 High & Low ph, Widest Selectivities UPLC Columns kit /pk BEH C, BEH C, BEH Shield RP, BEH Phenyl BEH:. µm.0 x 00 mm 00 UPLC Method Development Scouting kit /pk BEH C, BEH Shield RP, BEH Phenyl, HSS T BEH:. µm, HSS:. µm. x 0 mm 000 UPLC Method Development Scouting kit /pk BEH C, BEH Shield RP, BEH Phenyl, HSS T BEH:. µm, HSS:. µm. x 00 mm 000 UPLC Method Development Scouting kit /pk BEH C, BEH Shield RP, BEH Phenyl, HSS T BEH:. µm, HSS:. µm.0 x 0 mm 00 UPLC Method Development Scouting kit /pk BEH C, BEH Shield RP, BEH Phenyl, HSS T BEH:. µm, HSS:. µm.0 x 00 mm 00 L UPLC Columns kit /pk BEH C, BEH Shield RP, HSS C, HSS T BEH:. µm, HSS:. µm. x 0 mm 000 L UPLC Columns kit /pk BEH C, BEH Shield RP, HSS C, HSS T BEH:. µm, HSS:. µm. x 00 mm 000 L UPLC Columns kit /pk BEH C, BEH Shield RP, HSS C, HSS T BEH:. µm, HSS:. µm.0 x 0 mm 00 L UPLC Columns kit /pk BEH C, BEH Shield RP, HSS C, HSS T BEH:. µm, HSS:. µm.0 x 00 mm 00 Mass Spec UPLC Columns kit /pk BEH C, HSS C, HSS C SB, HSS T BEH:. µm, HSS:. µm. x 0 mm 000 Mass Spec UPLC Columns kit /pk BEH C, HSS C, HSS C SB, HSS T BEH:. µm, HSS:. µm. x 00 mm 000 Mass Spec UPLC Columns kit /pk BEH C, HSS C, HSS C SB, HSS T BEH:. µm, HSS:. µm.0 x 0 mm 00 Mass Spec UPLC Columns kit /pk BEH C, HSS C, HSS C SB, HSS T BEH:. µm, HSS:. µm.0 x 00 mm 00 Low ph, Widest Selectivities UPLC Columns kit /pk BEH Shield RP, BEH Phenyl, HSS C, HSS C SB BEH:. µm, HSS:. µm. x 0 mm 0009 Low ph, Widest Selectivities UPLC Columns kit /pk BEH Shield RP, BEH Phenyl, HSS C, HSS C SB BEH:. µm, HSS:. µm. x 00 mm 000 Low ph, Widest Selectivities UPLC Columns kit /pk BEH Shield RP, BEH Phenyl, HSS C, HSS C SB BEH:. µm, HSS:. µm.0 x 0 mm 009 Low ph, Widest Selectivities UPLC Columns kit /pk BEH Shield RP, BEH Phenyl, HSS C, HSS C SB BEH:. µm, HSS:. µm.0 x 00 mm 0090 UPLC RP and HILIC Method Development Scouting kit /pk BEH C, BEH Shield RP, BEH Amide, HSS C SB BEH:. µm, HSS:. µm. x 0 mm 0099 UPLC RP and HILIC Method Development Scouting kit /pk BEH C, BEH Shield RP, BEH Amide, HSS C SB BEH:. µm, HSS:. µm. x 00 mm 0090 UPLC RP and HILIC Method Development Scouting kit /pk BEH C, BEH Shield RP, BEH Amide, HSS C SB BEH:. µm, HSS:. µm.0 x 0 mm 009 UPLC RP and HILIC Method Development Scouting kit /pk BEH C, BEH Shield RP, BEH Amide, HSS C SB BEH:. µm, HSS:. µm.0 x 00 mm 009 UPLC HILIC Method Development Scouting kit /pk BEH Amide, BEH HILIC BEH. µm. x 0 mm 009 UPLC HILIC Method Development Scouting kit /pk BEH Amide, BEH HILIC BEH. µm. x 00 mm 009 UPLC HILIC Method Development Scouting kit /pk BEH Amide, BEH HILIC BEH. µm.0 x 0 mm 009 UPLC HILIC Method Development Scouting kit /pk BEH Amide, BEH HILIC BEH. µm.0 x 00 mm 009 New ACQUITY UPLC Method Transfer Kits* ACQUITY UPLC Columns Method Validation Kits Package Name UPLC Column. mm I.D. HPLC Column. mm I.D. Part No. BEH C. to µm Method Transfer kit 0 mm,. µm 0 mm, µm 009 BEH Shield RP. to µm Method Transfer kit 0 mm,. µm 0 mm, µm 0099 BEH HILIC. to µm Method Transfer kit 0 mm,. µm 0 mm, µm 0090 HSS C. to µm Method Transfer kit 0 mm,. µm 0 mm, µm 009 HSS T. to µm Method Transfer kit 0 mm,. µm 0 mm, µm 009 HSS C SB. to µm Method Transfer kit 0 mm,. µm 0 mm, µm 009 BEH C. to. µm Method Transfer kit 0 mm,. µm 00 mm,. µm 009 BEH Shield RP. to. µm Method Transfer kit 0 mm,. µm 00 mm,. µm 009 BEH HILIC. to. µm Method Transfer kit 0 mm,. µm 00 mm,. µm 009 BEH Amide. to. µm Method Transfer kit 0 mm,. µm 00 mm,. µm 009 HSS C. to. µm Method Transfer kit 0 mm,. µm 00 mm,. µm 009 HSS T. to. µm Method Transfer kit 0 mm,. µm 00 mm,. µm 0099 HSS C SB. to. µm Method Transfer kit 0 mm,. µm 00 mm,. µm 0090 BEH C. to. µm High Rs Method Transfer kit 00 mm,. µm 0 mm,. µm 009 BEH Shield RP. to. µm High Rs Method Transfer kit 00 mm,. µm 0 mm,. µm 009 BEH HILIC. to. µm High Rs Method Transfer kit 00 mm,. µm 0 mm,. µm 009 BEH Amide. to. µm High Rs Method Transfer kit 00 mm,. µm 0 mm,. µm 009 HSS C. to. µm High Rs Method Transfer kit 00 mm,. µm 0 mm,. µm 009 HSS T. to. µm High Rs Method Transfer kit 00 mm,. µm 0 mm,. µm 009 HSS C SB. to. µm High Rs Method Transfer kit 00 mm,. µm 0 mm,. µm 009 Chemistry Particle Size Column Length Part No.. mm I.D. Part No..0 mm I.D. BEH C. µm 0 mm BEH C. µm 00 mm BEH C. µm 0 mm BEH C. µm 00 mm BEH Shield RP. µm 0 mm BEH Shield RP. µm 00 mm BEH Phenyl. µm 0 mm BEH Phenyl. µm 00 mm BEH HILIC. µm 0 mm BEH HILIC. µm 00 mm BEH Amide. µm 0 mm BEH Amide. µm 00 mm HSS T. µm 0 mm HSS T. µm 00 mm HSS C. µm 0 mm HSS C. µm 00 mm HSS C SB. µm 0 mm HSS C SB. µm 00 mm * Each kit contains one UPLC Column, one HPLC column and an ACQUITY UPLC Columns Calculator. For a complete listing of ACQUITY UPLC column part numbers, please reference the ACQUITY UPLC Column Solution Brochure (literature number 0000EN) or visit us on the web at [ 9 ]

10 Sales ffices Austria and European Export (Central South Eastern Europe, CIS and Middle East) 0 Australia 99 Belgium 000 Brazil 09- Canada 00 x0 China 9 CIS/Russia +9 90/90 9 Czech Republic 0 Denmark 9 00 Finland 09 9 France 0 00 Germany Hong Kong 9 00 The Netherlands 0 00 Norway 0 0 Poland 00 Puerto Rico Singapore 9 00 Spain Sweden 00 Switzerland 0 00 Taiwan 9 United Kingdom 0 00 All other countries: Waters Corporation U.S.A Hungary 0 0 India and India Subcontinent Ireland 00 Italy Japan 09 Korea Mexico The quality management system of Waters manufacturing facilities in Taunton, Massachusetts and Wexford, Ireland complies with the International Standard IS 900:000 Quality Management and Quality Assurance Standards. Waters quality management system is periodically audited by the registering body to ensure compliance. 00 Waters Corporation. Waters, UltraPerformance LC, ACQUITY UPLC, ACQUITY, UPLC, XBridge, Alliance, BEH Technology, and The Science of What s Possible are trademarks of Waters Corporation. 000EN January 00 IH-FP