Blog

GC/MS Compliance

03 June 2024

(Download: GC/MS Compliance in PDF by Medistri)

GC/MS Analysis (also called Gas Chromatography/ Mass Spectrometry) is an analytical process that utilises the capabilities of Mass Spectrometry and Gas Chromatography in order to determine the chemical compounds within a sample.

GC/MS Analysis are recognised for being one of the most highly reliable and effective analysis for the pharmaceutical, Biotechnology & Medical Device industries.

Gas Chromatography-Mass Spectrometry (GC/MS) is a crucial analytical tool that combines the capabilities of gas chromatography and mass spectrometry. It’s importance lies in its ability to provide enhanced sample identification. The gas chromatography component separates volatile components in a sample, and the mass spectrometry part helps fragment the components and identify them based on their mass.

GC/MS Analysis can identify both volatile and semi-volatile chemical compounds. Medistri’s laboratory can analyse both liquid and gas compounds using the direct injection method into gas chromatography - allowing for a large scope of applications:

  • VOC & SVOC Testing.
  • Residual Analysis.
  • Compound Separations.
  • Compliance.
  • Identification and Quantification.
  • Material Outgassing Testing.
  • Identification of Debris & Contamination.
  • Identification Impurities.
  • Identification of Potential Extractables and Leachables.

Our laboratory works according to ISO 17025 (current version) and is accredited since 2008 by the Swiss Accreditation Service (SAS). All testing can be performed according to European or US pharmacopeias.

ISO17025 is the international standard for testing and calibration laboratories. It sets out requirements for the competence, impartiality, and consistent operation of laboratories, ensuring the accuracy and reliability of their testing and calibration results.

This standard is vital for laboratories as it enhances the credibility of their testing and calibration work, fostering trust among clients and regulatory authorities. Compliance with ISO17025 demonstrates a laboratory’s commitment to quality, technical proficiency, and scientific rigor. It also establishes a global benchmark for laboratory quality and reliability, enhances confidence in test and calibration results, both domestically and internationally, and reduces the need for retesting, saving time and resources.

🎯 To learn more about Medistri’s GC/MS Compliance, visit on our website here or directly contact our team at contact@medistri.swiss.

- The Medistri Team

#Medistri