Advanced Sample Preparation Combined with Mass Spectrometric Detection (HRAM, TQ) for Analyzing Pharmaceutical, Consumer Products and Medical Devices

Sample preparation is one of the most important steps of the analytical process and has the largest impact on the quality and the reliability of the analytical data package. The three major reasons for performing sample preparation are the following.

• Reduce or eliminate sample incompatibility with the analytical systems (analysis of solid samples with gas or liquid chromatography-based technique)
• Eliminate heavy matrix components and reduce matrix interferences
• Concentrate the samples

A “good” sample preparation method would meet the following requirements:

• Non discriminative for the targets and discriminative for the matrix interferences
• Result of the extraction is predictable
• Quick
• Cost effective
• Automated
• Complies with current regulations and regulatory expectations
• Highly repeatable
• Easy to perform
• Safe for the environment

Depending of the target analyte group, different sample preparation techniques should be used in the analytical process. Mass spectrometry, hyphenated with chromatographic separation, has a long and successful history of analyzing finished product of different natures (pharmaceuticals, medical devices, and consumer products). Its versatility, unmatched low detection limit, and capability to detect a wide range of organic compounds makes it ideal to characterize those various finished products. Mass spectrometry can be used for high-sensitivity targeted analysis, as well as non-targeted screening, and it is also an excellent research tool for identifying previously unknown chemical entities.

Recently, the relatively easy access to tandem (MS/MS) and high-resolution accurate mass based systems (HRAM), can lower the detection limit of high-risk targeted analytes. To enhance the productivity of the mass spectrometric detection, it is very often combined with an automated sample preparation option such as static head-space or SPME. This presentation will focus on presenting case studies for using various high-performance sample preparation methods in combination with either HRAM or MS/MS detection.

Presenter: Gyorgy Vas, Ph.D. (Owner, VasAnalytical)

“Research is four things: brains with which to think, eyes with which to see, machines with which to measure, and fourth, money.” - Prof. Albert Szent-Gyorgyi

Gyorgy Vas has over 20 years of experience in scientific research, product development, and laboratory management. More than half of this time was spent in a cGMP environment, where that scientific expertise was applied to solve problems related to finished pharmaceutical products and medical devices. In his current position, he is advising regulatory filing strategy for multiple clients, and his group provides solutions to mitigate deficiency letters. He made significant achievements to implement state-of-the-art solventless sample preparation techniques into the cGMP laboratory processes. Gyorgy is one of the few persons in the field with expertise in method development and validation for ultratrace (parts-per-trillion) level impurities in finished pharmaceutical products and medical devices.

Recently he is focusing on applications of HRAM technology hyphenated with gas chromatography to evaluate trace-level impurities in food and pharmaceutical products.