The Tech

The demand to develop ground-breaking pharmaceuticals and generics faster has never been higher. It’s where the presence of harmful impurities simply cannot be missed. That’s why to be fully confident about what your lab is doing—and to stay abreast of changing standards with innovative approaches—you must be built to evolve. You must be modernized in a way that allows you to constantly monitor and continually assess risk with greater collaboration and global sharing of critical data. Turning unknowns into knowns, up and down your development process, with the highest degree of accuracy. Where mission-critical meets life-critical is where you’ll find Waters. Helping you ensure the quality, safety and efficacy of the drugs that heal us today while always being prepared for the threats of tomorrow.

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Using inexpensive and non-toxic compressed liquid CO2 as a primary mobile phase, ACQUITY UPC2 gives you the ability to precisely vary mobile phase strength, pressure, and temperature. A single solvent system approach can determine enantiomeric impurities and provide orthogonality for specificity assessments of the achiral impurity profiles.

The comprehensive suite of ACQUITY UPLC Columns drives and enables impurity method development strategies. Our columns and ISO regulated manufacturing process helps you achieve reproducible, scalable, transferable and reliable impurity profile separations.

When developing impurity profiles, ACQUITY UPLC H-Class provides method development flexibility by allowing you to screen many method variables quickly and automatically.

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Isolate UPLC impurity peaks less than 6 seconds wide to attain micrograms of impurity material suitable for state-of-the-art cryogenic NMR determinations.

Optimum Bed Density (OBD™) Technology combined with Mass Directed Autopurification allows you to load large quantities of isolated impurity, facilitating identification and quantification.

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From the powerful family of tandem quad instruments, Xevo TQ-S micro allows you to inject less sample more precisely, while detecting impurities at low concentrations in complex matrices.

Waters’ new high-performance benchtop Tof allows you to correlate related impurities to the API, and unrelated process impurities with a single injection via high and low collision energy data.

UNIFI is an enterprise information system capable of building proprietary libraries made up of observed impurity data collected throughout an organization. Public databases can be accessed and identification of known and unknown impurities is facilitated by elucidation tools.

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Designed for chromatographers, the QDa Detector is well-adapted to speed method development via efficient peak tracking and minimizes the risk of missing co-elutions.

ACQUITY Arc delivers productivity gains through a single LC platform for both HPLC and UHPLC separations. Modernize your impurity methods vis-à-vis USP chapter <621> and the ICH Q12 guideline regarding lifecycle management.

A holistically compliant CDS with >300,000 users, Empower ICH impurity processing, Method Validation Manager, and Nugenesis stability module are the make-up of the gold standard for informatics focused toward impurity analysis.

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