With the GERSTEL MPS you can efficiently and reliably automate your sample preparation and

injection for

GC & GC/MS Analysis

Liquid Injection Each version of the MPS provides the widest range of liquid injec-tion techniques from standard 1-2 µL volumes to sandwich or large-volume injections (LVI) of up to 1000 µL. Reproducible, car-ryover free and non-discriminatory liquid sample introduction is guaranteed with the MPS.

Headspace Injection (sample volumes up to 2.5 mL)MPS stands for maximum productiv-ity. The PrepAhead feature of the MAESTRO software allows you to intelligently interlace incubation and analysis cycles and optimize the use of your GC/MS system. Carryover is avoided by using heat-ed syringes and flushing with inert gas.

SPME & Automated Fiber Exchange (MFX)With the MPS your SPME analysis is completely automated – from the conditioning of the fiber and the extraction of the sample, to desorption and subsequent GC/MS analysis. Derivatization on the fiber and the addition of reagents before or after extraction are standard options in MAESTRO software. The fully auto-mated exchange of up to 25 SPME fibers is also available.

Dynamic Headspace (DHS)With the DHS you can significantly improve the efficiency of your headspace analysis. The head-space above solid, viscous or liquid samples is exhaustively ex-tracted with inert gas; analytes are efficiently trapped in an exchange-able sorbent tube of your choosing. Theanalytes are thermally desorbed using the GERSTEL Thermal Desorption Unit (TDU) and analyzed using GC/MS. The entire process is automated, providing excellent reproducibility and extremely low detection limits.

Thermal ExtractionUsing the GERSTEL Thermal Desorption Unit (TDU) the MPS allows automated thermal extraction of solid and liquid samples. Difficult matrix or viscous samples are automati-cally injected into micro vials and thermally extracted using the TDU. The used vials are disposed of, eliminating carry over and contami-nation of your GC/MS system.

PyrolysisThe pyrolysis option for the MPS/TDU can automate the pyrolysis of up to 98 liquid or solid samples. Flexible temperature control allows sam-ple heating and data collection over a wide temperature range providing maximum information on sample composition.

Liquid Handling and Sample PreparationMAESTRO software control of the MPS is intuitive, making the automation of all steps of liquid handling and sample preparation easy and efficient. For example:• Derivatization and addition of internal standards• Dilution and extraction• Heated or cooled conditioning/mixing of samples • Centrifuging and weighing • Barcode reading

GERSTEL Twister (Stir Bar Sorptive Extraction)Ultra trace detection of organic compounds from aqueous and gaseous samples is achieved by analyte sorption onto a large volume PDMS phase. Analytes are then thermally de-sorbed from the Twister using the TDU. The process can be com-pletely automated using the MPS with the Twister automation option.

Automated Solid Phase Extraction (SPE)With the GERSTEL SPE option, solid-phase extraction with standard SPE cartridges is done automati-cally. The system includes solvent evaporation and the solvent ex-change capability. The SPE process is controlled easily and efficiently using MAESTRO software. Manual methods can simply be transferred and automated.

Dispersive SPEIn contrast to the classic SPE cartridge, the solid phase material in the automated GERSTEL Disposable Pipette Extraction (DPX) is not packed, but dispersed in a pipette tip. The dispersion of the SPE phase greatly accelerates the extraction process and the required sample volumes are significantly reduced.

Automated GC Liner EXchange (ALEX)When combined with the GERSTEL Automated Liner Exchange (ALEX) option and the GERSTEL Cooled Injection System (CIS) the MPS can be programmed to change the GC liner automatically. The frequent, automated changing of the inlet liner keeps the GC column and MS clean, even when analyzing dirty samples, such as QuEChERS extracts.

For more information please contact us:

GERSTEL GmbH & Co. KGEberhard-Gerstel-Platz 1

45473 Mülheim an der Ruhr

gerstel@gerstel.com

or visit

www.gerstel.com

The GERSTEL Dynamic Headspace System (DHS) in combination with a GC/MS system allows the determination of trace amounts of volatile compounds in a wide variety of sample matrices.

Pharmaceutical Solutions

Gas Chromatography

Metabolite Profiling

USP <467>

GTIs/PGIs

FAME

Extractables & Leachables

www.gerstel.com

USP <467>Detection of residual solvents/organic volatile impurities (OVI) in pharmaceutical products, active pharmaceutical agents and excipients via headspace gas chromatography and flame ionization detection (HS-GC/FID) – GERSTEL offers a completely automated [USP <467>] solution which meets the requirements set by the USP mono-graph (US Pharmacopeia 467). This solution is based on the GERSTEL MultiPurpose Sampler (MPS) with multi-sample PrepAhead incubation in connection with a GC/FID system by Agilent Technologies. This effective combi-nation allows you to increase the efficiency of your head-space analysis and enhance the precision, accuracy and linearity of the determination of all compounds including emerging compounds of interest such as acetic acid. [1]

Extractables & LeachablesDetermination of leachable chemicals in pharmaceutical packaging. – The required “Extractable & Leachable” studies are based on guidelines of the US Pharmacopeia (<381> and <661>), the FDA and the EMEA. FDA Guidelines for migration studies in food packaging also exist. You can mas-ter the systematic entry into packaging analysis with thermal-extraction GC/MS: it is suitable for the efficient and solvent-free extraction of volatile and semi-volatile compounds. With solutions based on the GERSTEL Thermal Desorption System, you will get an excellent qualitative and quantitative overview of any potential contamination. [10, 11]

Stir Bar Sorptive Extraction (SBSE) using the GERSTEL Twister has been widely used for E&L work. As an example a validated SBSE-TD-GC/MS method was successfully used for trouble-shooting in a recent major product recall associ-ated with off flavors in packaging. [12]

Genotoxic Impurities GTIs/PGIsMonitoring harmful ethyl methane sulfonate (EMS) forma-tion in pharmaceutical drugs. Sulfonic acids are used in the synthesis and production of pharmaceutical ingredients. – Under unfavorable conditions sulfonic acid reacts with low-molecular alcohols to form ethyl methane sulfonate (EMS). The Headspace-GC/MS system by GERSTEL pro-vides a powerful complete system that allows you to reliably monitor EMS formation. All steps for the sample prepara-tion, including derivatization, and the GC/MS analyses are automated. The system allows unsupervised operation over long periods of time and provides excellent value in terms of repeatability, linearity and robustness. [8]

Metabolite ProfilingMonitoring of biological and enzymatic processes and metabolic reactions on a miniature scale. – In the middle of the previous century scientists had the idea to diagnose metabolic diseases by determining the concentration of amino acids. Gas chromatography in combination with mass-selective detection (GC/MS) offers ideal conditions for the quantification not only of amino acids in biological matrices, but also allows easy monitoring and the exact reproduction of enzy-matic and complex metabolic processes. GERSTEL offers you a range of complete systems for performing your metabolite profiling automated, efficiently and safely, in the headspace vial. [2, 3, 4, 5, 6, 7]

In the areas of biotechnology, biomedi-cal sciences and the growing pharma-ceutical industry GERSTEL offers GC (GC/MS) solutions for a number of ap-plications. Their operation conforms to CLP; the software can be set up to be consistent with 21 CFR Part 11. GERSTEL also offers IQ/OQ-PV for the entire system.

FAMEsFocus on fatty acid methyl esters (FAMEs) Animal and veg-etable fats are key components in our nutrition. – However, their determination also plays an important role in the dif-ferent steps of pharmaceutical development and quality management. In order to determine FAMEs via gas chro-matography, they have to be hydrolyzed and derivatized. The GERSTEL PrepStation in combination with GC/MS or GC/TOFMS and controlled by GERSTEL Maestro software is ideally suited for this application. The system automates all steps of the sample preparation, injection and data collec-tion. The samples are prepared “just-in-time” assuring that each sample has been prepared and injected in exactly the same manner. [9]

MAESTRO SoftwareSample preparation and sample introduction perfectly synchronized. – The MAESTRO software operates all GERSTEL modules and system solutions in a simple and efficient manner. MAESTRO can be operated as stand-alone software or fully integrated with the Agilent Technologies ChemStation. Just one method and one sequence table runs the complete system from Sample Prep and Sample Introduction to GC/MS or LC/MS analysis. Set-up is performed in a very simple manner: By mouse-click.

Pharmaceutical solutions based on intelligently

automated sample preparation for GC and GC/MS

References[1] John R. Stuff, Jacqueline A. Whitecava-ge: Implementation of USP <467> Residu-al Solvents using a GERSTEL MPS Syringe Based Headspace Autosampler, GERSTEL AppNote 9/2009 (www.gerstel.com/Appli-kation)

[2] K. Dettmer: Fully automated GC/MS determination of amino acids, GERSTEL Solutions worldwide 10 (03/2010) pg. 18-19

[3] T. Grimm, E. Kleine-Benne, R. Senz, C. Piechotta: SPME-Headspace-Technik zur Analyse von Stoffwechselprozessen, LaborPraxis 32 (10/2008) pg. 46-49 and GERSTEL Aktuell 43 (11/2010) pg. 10-12

[4] Pete Stevens: Asparagus on the menu. Efficient detection of Sulfur-Containing Metabolites of Asparagus in Urine by SBSE-GCxGC-TOFMS; GERSTEL Solutions worldwide 10 (3/2010) pg. 10/11

[5] D.Y. Lee, O. Fiehn: High quality metabo-lomic data for chlamydomonas reinhard-tii, Plant Methods 2008, 4-7

[6] O. Fiehn: Extending the breadth of me-tabolite profiling by gas chromatography coupled to mass spectrometry, Trends in Analytical Chemistry 2008, 27(3), 261-269

[7] O. Fiehn, G. Wohlgemuth, M. Scholz, T. Kind, D.Y. Lee, Y. Lu, S. Moon, B.J. Nikolau: Quality control for plant metabo-lomics: Reporting MSI-compliant studies, Plant Journal 2008, 53, 691-704

[8] Karine Jacq et al.: Development and va-lidation of an automated static headspace gas chromatography-mass spectrometry (SHS-GC-MS) method for monitoring of ethyl methane sulfonate from ethanol and methane sulfonic acid, Journal of Phar-maceutical and Biomedical Analysis 48 (2008) 1339-1344.

[9] Determining FAMEs with just-in-time sample preparation, GERSTEL Solutions worldwide 9 (03/2009) pg. 8-11

[10] M. Jahn, A. Hauk: Illegal migration, GERSTEL Solutions worldwide 10 (3/2010) pg. 20-22.

[11] Cindy Zweiben, Arthur J. Shaw: Use of Thermal Desorption GC-MS to Characteri-ze Packaging Materials for Potential Extrac-tables, PDA Journal of Pharmaceutical Sci-ence and Technology 63 (2009) 353-359.

[12] Method Development and Validation for the Determination of 2,4,6-TBA, 2,4,6-TBP, 2,4,6-TCA and 2,4,6-TCP in Various Drug Products Using SBSE-GC-Tandem MS.

USP <467>Detection of residual solvents/organic volatile impurities (OVI) in pharmaceutical products, active pharmaceutical agents and excipients via headspace gas chromatography and flame ionization detection (HS-GC/FID) – GERSTEL offers a completely automated [USP <467>] solution which meets the requirements set by the USP mono-graph (US Pharmacopeia 467). This solution is based on the GERSTEL MultiPurpose Sampler (MPS) with multi-sample PrepAhead incubation in connection with a GC/FID system by Agilent Technologies. This effective combi-nation allows you to increase the efficiency of your head-space analysis and enhance the precision, accuracy and linearity of the determination of all compounds including emerging compounds of interest such as acetic acid. [1]

Extractables & LeachablesDetermination of leachable chemicals in pharmaceutical packaging. – The required “Extractable & Leachable” studies are based on guidelines of the US Pharmacopeia (<381> and <661>), the FDA and the EMEA. FDA Guidelines for migration studies in food packaging also exist. You can mas-ter the systematic entry into packaging analysis with thermal-extraction GC/MS: it is suitable for the efficient and solvent-free extraction of volatile and semi-volatile compounds. With solutions based on the GERSTEL Thermal Desorption System, you will get an excellent qualitative and quantitative overview of any potential contamination. [10, 11]

Stir Bar Sorptive Extraction (SBSE) using the GERSTEL Twister has been widely used for E&L work. As an example a validated SBSE-TD-GC/MS method was successfully used for trouble-shooting in a recent major product recall associ-ated with off flavors in packaging. [12]

Genotoxic Impurities GTIs/PGIsMonitoring harmful ethyl methane sulfonate (EMS) forma-tion in pharmaceutical drugs. Sulfonic acids are used in the synthesis and production of pharmaceutical ingredients. – Under unfavorable conditions sulfonic acid reacts with low-molecular alcohols to form ethyl methane sulfonate (EMS). The Headspace-GC/MS system by GERSTEL pro-vides a powerful complete system that allows you to reliably monitor EMS formation. All steps for the sample prepara-tion, including derivatization, and the GC/MS analyses are automated. The system allows unsupervised operation over long periods of time and provides excellent value in terms of repeatability, linearity and robustness. [8]

Metabolite ProfilingMonitoring of biological and enzymatic processes and metabolic reactions on a miniature scale. – In the middle of the previous century scientists had the idea to diagnose metabolic diseases by determining the concentration of amino acids. Gas chromatography in combination with mass-selective detection (GC/MS) offers ideal conditions for the quantification not only of amino acids in biological matrices, but also allows easy monitoring and the exact reproduction of enzy-matic and complex metabolic processes. GERSTEL offers you a range of complete systems for performing your metabolite profiling automated, efficiently and safely, in the headspace vial. [2, 3, 4, 5, 6, 7]

In the areas of biotechnology, biomedi-cal sciences and the growing pharma-ceutical industry GERSTEL offers GC (GC/MS) solutions for a number of ap-plications. Their operation conforms to CLP; the software can be set up to be consistent with 21 CFR Part 11. GERSTEL also offers IQ/OQ-PV for the entire system.

FAMEsFocus on fatty acid methyl esters (FAMEs) Animal and veg-etable fats are key components in our nutrition. – However, their determination also plays an important role in the dif-ferent steps of pharmaceutical development and quality management. In order to determine FAMEs via gas chro-matography, they have to be hydrolyzed and derivatized. The GERSTEL PrepStation in combination with GC/MS or GC/TOFMS and controlled by GERSTEL Maestro software is ideally suited for this application. The system automates all steps of the sample preparation, injection and data collec-tion. The samples are prepared “just-in-time” assuring that each sample has been prepared and injected in exactly the same manner. [9]

MAESTRO SoftwareSample preparation and sample introduction perfectly synchronized. – The MAESTRO software operates all GERSTEL modules and system solutions in a simple and efficient manner. MAESTRO can be operated as stand-alone software or fully integrated with the Agilent Technologies ChemStation. Just one method and one sequence table runs the complete system from Sample Prep and Sample Introduction to GC/MS or LC/MS analysis. Set-up is performed in a very simple manner: By mouse-click.

Pharmaceutical solutions based on intelligently

automated sample preparation for GC and GC/MS

References[1] John R. Stuff, Jacqueline A. Whitecava-ge: Implementation of USP <467> Residu-al Solvents using a GERSTEL MPS Syringe Based Headspace Autosampler, GERSTEL AppNote 9/2009 (www.gerstel.com/Appli-kation)

[2] K. Dettmer: Fully automated GC/MS determination of amino acids, GERSTEL Solutions worldwide 10 (03/2010) pg. 18-19

[3] T. Grimm, E. Kleine-Benne, R. Senz, C. Piechotta: SPME-Headspace-Technik zur Analyse von Stoffwechselprozessen, LaborPraxis 32 (10/2008) pg. 46-49 and GERSTEL Aktuell 43 (11/2010) pg. 10-12

[4] Pete Stevens: Asparagus on the menu. Efficient detection of Sulfur-Containing Metabolites of Asparagus in Urine by SBSE-GCxGC-TOFMS; GERSTEL Solutions worldwide 10 (3/2010) pg. 10/11

[5] D.Y. Lee, O. Fiehn: High quality metabo-lomic data for chlamydomonas reinhard-tii, Plant Methods 2008, 4-7

[6] O. Fiehn: Extending the breadth of me-tabolite profiling by gas chromatography coupled to mass spectrometry, Trends in Analytical Chemistry 2008, 27(3), 261-269

[7] O. Fiehn, G. Wohlgemuth, M. Scholz, T. Kind, D.Y. Lee, Y. Lu, S. Moon, B.J. Nikolau: Quality control for plant metabo-lomics: Reporting MSI-compliant studies, Plant Journal 2008, 53, 691-704

[8] Karine Jacq et al.: Development and va-lidation of an automated static headspace gas chromatography-mass spectrometry (SHS-GC-MS) method for monitoring of ethyl methane sulfonate from ethanol and methane sulfonic acid, Journal of Phar-maceutical and Biomedical Analysis 48 (2008) 1339-1344.

[9] Determining FAMEs with just-in-time sample preparation, GERSTEL Solutions worldwide 9 (03/2009) pg. 8-11

[10] M. Jahn, A. Hauk: Illegal migration, GERSTEL Solutions worldwide 10 (3/2010) pg. 20-22.

[11] Cindy Zweiben, Arthur J. Shaw: Use of Thermal Desorption GC-MS to Characteri-ze Packaging Materials for Potential Extrac-tables, PDA Journal of Pharmaceutical Sci-ence and Technology 63 (2009) 353-359.

[12] Method Development and Validation for the Determination of 2,4,6-TBA, 2,4,6-TBP, 2,4,6-TCA and 2,4,6-TCP in Various Drug Products Using SBSE-GC-Tandem MS.

With the GERSTEL MPS you can efficiently and reliably automate your sample preparation and

injection for

GC & GC/MS Analysis

Liquid Injection Each version of the MPS provides the widest range of liquid injec-tion techniques from standard 1-2 µL volumes to sandwich or large-volume injections (LVI) of up to 1000 µL. Reproducible, car-ryover free and non-discriminatory liquid sample introduction is guaranteed with the MPS.

Headspace Injection (sample volumes up to 2.5 mL)MPS stands for maximum productiv-ity. The PrepAhead feature of the MAESTRO software allows you to intelligently interlace incubation and analysis cycles and optimize the use of your GC/MS system. Carryover is avoided by using heat-ed syringes and flushing with inert gas.

SPME & Automated Fiber Exchange (MFX)With the MPS your SPME analysis is completely automated – from the conditioning of the fiber and the extraction of the sample, to desorption and subsequent GC/MS analysis. Derivatization on the fiber and the addition of reagents before or after extraction are standard options in MAESTRO software. The fully auto-mated exchange of up to 25 SPME fibers is also available.

Dynamic Headspace (DHS)With the DHS you can significantly improve the efficiency of your headspace analysis. The head-space above solid, viscous or liquid samples is exhaustively ex-tracted with inert gas; analytes are efficiently trapped in an exchange-able sorbent tube of your choosing. Theanalytes are thermally desorbed using the GERSTEL Thermal Desorption Unit (TDU) and analyzed using GC/MS. The entire process is automated, providing excellent reproducibility and extremely low detection limits.

Thermal ExtractionUsing the GERSTEL Thermal Desorption Unit (TDU) the MPS allows automated thermal extraction of solid and liquid samples. Difficult matrix or viscous samples are automati-cally injected into micro vials and thermally extracted using the TDU. The used vials are disposed of, eliminating carry over and contami-nation of your GC/MS system.

PyrolysisThe pyrolysis option for the MPS/TDU can automate the pyrolysis of up to 98 liquid or solid samples. Flexible temperature control allows sam-ple heating and data collection over a wide temperature range providing maximum information on sample composition.

Liquid Handling and Sample PreparationMAESTRO software control of the MPS is intuitive, making the automation of all steps of liquid handling and sample preparation easy and efficient. For example:• Derivatization and addition of internal standards• Dilution and extraction• Heated or cooled conditioning/mixing of samples • Centrifuging and weighing • Barcode reading

GERSTEL Twister (Stir Bar Sorptive Extraction)Ultra trace detection of organic compounds from aqueous and gaseous samples is achieved by analyte sorption onto a large volume PDMS phase. Analytes are then thermally de-sorbed from the Twister using the TDU. The process can be com-pletely automated using the MPS with the Twister automation option.

Automated Solid Phase Extraction (SPE)With the GERSTEL SPE option, solid-phase extraction with standard SPE cartridges is done automati-cally. The system includes solvent evaporation and the solvent ex-change capability. The SPE process is controlled easily and efficiently using MAESTRO software. Manual methods can simply be transferred and automated.

Dispersive SPEIn contrast to the classic SPE cartridge, the solid phase material in the automated GERSTEL Disposable Pipette Extraction (DPX) is not packed, but dispersed in a pipette tip. The dispersion of the SPE phase greatly accelerates the extraction process and the required sample volumes are significantly reduced.

Automated GC Liner EXchange (ALEX)When combined with the GERSTEL Automated Liner Exchange (ALEX) option and the GERSTEL Cooled Injection System (CIS) the MPS can be programmed to change the GC liner automatically. The frequent, automated changing of the inlet liner keeps the GC column and MS clean, even when analyzing dirty samples, such as QuEChERS extracts.

For more information please contact us:

GERSTEL GmbH & Co. KGEberhard-Gerstel-Platz 1

45473 Mülheim an der Ruhr

gerstel@gerstel.com

or visit

www.gerstel.com

Liquid Injection Thermal Extraction

The GERSTEL Dynamic Headspace System (DHS) in combination with a GC/MS system allows the determination of trace amounts of volatile compounds in a wide variety of sample matrices.

Pharmaceutical Solutions

Gas Chromatography

Metabolite Profiling

USP <467>

GTIs/PGIs

FAME

Extractables & Leachables

www.gerstel.com