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Achieving method modernization with the new liquid chromatographic gradient allowances provided by USP General Chapter <621> Chromatography and the Alliance iS HPLC System

Waters
23 Jul 2023

The extent to which the various parameters of a chromatographic test may be adjusted without fundamentally modifying the pharmacopeial analytical procedures is defined in U.S. Pharmacopeia (USP) General Chapter <621> Chromatography. In this application note, Waters combines the gradient method adjustments described in this chapter with the Alliance™ iS HPLC System to achieve both column dimension and system modernization for the USP monograph separation of antiviral drug, abacavir sulfate.

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Designed to meet the everyday challenges facing pharmaceutical quality control (QC) labs, the Alliance™ iS HPLC System delivers a new era of intuitive simplicity by reducing errors with innovative system intelligence, enhancing productivity with safeguards to ensure system performance, and maximizing system uptime. 

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UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.

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Achieving method modernization with the new liquid chromatographic gradient allowances provided by USP General Chapter <621> Chromatography and the Alliance iS HPLC System