Chromatography event looks at testing landscape in wake of NYAG affair

An upcoming event focused on chromatography illustrates the rapid developments in the field as well as the heightened demand for testing services in the wake of the NYAG affair.

The event, sponsored by Alkemsit Labs, Phenomenex and USP, will look at current challenges and opportunities for modernizing compendial methods, chromatography solutions and allowable adjustments to USP methods. The organizers say attendees will also have the opportunity to network with other industry leaders at the forefront of accurate and robust dietary supplement testing. Called the Southern California Dietary Supplements Chromatography Forum, the free event is scheduled for Thursday July 28, 2016 at the Phenomenex office in Torrance, California.

Elan Sudberg, CEO of Alkemist Labs said the demand for testing services has been on the rise, and that the activities of New York Attorney General Eric Schneiderman served to give it an added push.  The goal of the event is to help get the industry up to speed on fit-for-purpose testing.

We had already observed increased commitment to testing for several years, which we attribute to the industry stepping up GMP compliance. After the NYAG activities, the industry response has been an intensified interest in understanding testing coupled with a knee jerk demand for DNA testing, whether or not it’s appropriate,” Sudberg told NutraIngredients-USA.

New developments in the field

Chromatography has been around for a long time, but new developments meant that additional capabilities come on line all the time, said Philip Koerner, PhD, senior technical manager at Phenomenx.

In recent years there have been significant advances in both HPLC instrumentation systems as well as in column particle technologies and different stationary phases that provide different selectivities and alternatives to help labs determine purity and adulteration.  In addition, these advancements in HPLC column technologies can improve laboratory productivity and reduce cost.   More and more labs are looking to upgrade/update their existing methods with current up to date HPLC/UHPLC technologies and methods,” he said.

Koerner said that the cost to apply these new technologies would depend on a company’s needs and the equipment it already has in place. If a company already has an extensive amount of HPLC equipment on hand, employing the particle technologies would not necessarily break the bank. But one cost that is often overlooked is having the right personnel with the right training to correctly interpret results.

One of the specific segments of the upcoming event will focus on the ‘allowable adjustments’ in USP methods.  Koerner said that knowing how to apply the latest technologies is a key element to making USP compendial methods yield the best results at the lowest cost.

“With the availability of much higher efficiency HPLC and UHPLC columns, many of these methods could be improved to increase productivity in the lab and reduce the lengthy run times often associated with these methods, while maintaining or improving chromatographic resolution and meeting the system suitability requirements defined in the monograph,” he said.

 

“There are some allowable adjustments in isocratic and gradient separations such as : Mobile phases, pH buffer concentrations, column temperature, inner diameter, column length, flow rate, injection volume, particle size, and guards,” Koerner said.

The forum agenda includes:

  • Advancements in Chromatography for Dietary Supplements (presenter: Zeshan Aqeel, Applications Scientist, Phenomenex), 
  • Allowable Adjustments to USP Methods (presenter: Phil Koerner PhD, Technical Manager, Phenomenex), 
  • A Modern Chromatographic Approach to Deter Ginkgo Adulteration (presenter: Holly Johnson PhD, Laboratory Director, Alkemist Labs), 
  • C2C – Cuvette to Column – Updating Spectrophotometry to Chromatography in Compendial Monographs (presenter: Anton Bzhelyansky, Scientific Liaison, USP), 
  • Discussion on Compendial Method Modernization 
  • Tour of the Phenomenex manufacturing facility 

Sudberg said that the event could form part of an industry-wide effort toward a more robust supply chain, something that could form part of the armor against the industry’s more vocal critrics.

“The industry has been battered by negative media coverage, much of it off base, but it’s out there. We have to focus on long-term sustainability, which means a broader understanding of and commitment to fit for purpose testing,” he said.

For more information on the forum or to register, click here.