Dominic_AAPS_101711 KAREN

Slide 2: 

Beginning of Change In early 2009, Waters was approached to write a Stimuli Article to modernize and add more flexibility to selecting LC columns in Chromatography <621> Chromatography <621> describes the adjustments allowed in the chromatography system when system suitability test fails In the summer of 2009, Dr. Uwe Neue , et. al., wrote a paper that basically describes UPLC technology and method transfer from HPLC

Why Do You Need to Change?: 

Why Do You Need to Change? Modifying chromatographic procedure while being compliant Modifying column length, internal diameter, and mobile phase composition Chromatography <USP 621> contains a list of allowed adjustments to chromatographic systems. However the user should verify the suitability of the method under the new conditions by assessing the relevant analytical performance characteristics potentially affected by the change (See section System Suitability under Chromatography <621>)

Slide 4: 

Stimulus Article Stimuli Article allows the flexibility to change the column dimensions and/or particle size as long as an equivalent (or better) separation is achieved …. Promoted Flexibility

USP-NF Development Process: 

USP-NF Development Process Scientific Liaison forwards for publication in Pharmacopeial Forum Scientific liaison requests further information or revision Sponsor Request for Revision to USP Public comments (90 days) Expert committee reviews comments and accepts/rejects them Approved Not approved Comments and responses published in Pharmacopeial Forum Target Date for First Supplement to USP 35-NF 30 01 August 2011 Are You Ready?

Column Equivalency, Calculator & Selectivity : 

Column Equivalency, Calculator & Selectivity Column Selectivity Chart Provides an assessment of a column ’ s hydrophobicity and base/neutral selectivity Select “ equivalent ” column www.waters.com/selectivitychart L/dp To preserve the separation power of the gradient, L/dp must be matched Scalable Chemistry From 5 to 1.7 micron

Slide 7: 

Mometasone Furoate Diethyl Phthalate UPLC HPLC UPLC vs. HPLC: Mometasone Furoate Synthetic corticosteroid with anti-inflammatory activity Reduces inflammation by activating secretion of anti-inflammatory proteins and decreasing the influx of inflammatory cells

Slide 8: 

BENEFITS OF UPLC TECHNOLOGY Reduced LC instrumentation footprint Reduced solvent usage Reduced analysis time

The Future is NOW with ACQUITY UPLC H-Class: 

The Future is NOW with ACQUITY UPLC H-Class Remove the barriers to enhance your laboratory productivity

Slide 10: 

The Last Barrier is Removed