Application

Conducting E&L Studies more efficiently

To safeguard the health and well-being of patients, it must be ensured that no harmful chemical compounds can leach from packaging into a pharmaceutical product before it is administered or taken. This is done by conducting Extractables & Leachables (E&L) studies on pharmaceutical products in their packaging and by screening the packaging for potential extractable and leachable compounds, for example, using direct thermal desorption of the packaging material. Thermal Desorption (TD) coupled with GC/MS analysis has proven a highly efficient and sensitive screening method. Chemical compounds that are extractable and leachable are likely to be suitable for thermal extraction. TD Screening gives a first rate overview of potential contaminants covering a wide polarity range [1].

Application experts from Agilent Technologies and GERSTEL have now expanded the range of TD-related methods used for E&L studies to polymer based blood bags (IV bag systems) [2]. In this work, direct thermal extraction of the IV bag system material was used to provide an overview of the volatile compounds present. Hoffmann et al. then went one step further to extract and concentrate leached compounds from the IV bag content (simulants) using Stir Bar Sorptive Extraction (SBSE) based on the patented GERSTEL Twister. The added value of this approach: Labor and time-intensive solvent-based extraction and concentration procedures are eliminated. The GERSTEL Twister has a large sorbent phase volume enabling efficient extraction with good recovery resulting in high overall sensitivity of the analysis and low detection limits. In addition, the absence of an extraction solvent reduces the number of interfering compounds and eliminates solvent peak masking.

During thermal desorption, analytes are concentrated in the cold trap and subsequently transferred quantitatively to the GC/MS column whereas only an aliquot of liquid extracts are analyzed resulting in less favorable limits of detection. Results obtained on a quadropole GC/MS system were controlled using high resolution GC-QTOF-MS leading to a highly interesting correction of the results reported. In summary, TD screening enables a wide range of analytes to be determined with much lower limits of detection and GC-QTOF can help remove any doubt as to the identity of a leachable compound.

References

[1] Michael Jahn, Armin Hauk, Illegal Migration from Packaging, GERSTEL Solutions Worldwide No. 10 (2010) 20-23, http://www.gerstel.com/pdf/GST_GSW_10_20_22.pdf
[2] Elizabeth Almasi, Andreas Hoffmann, Thomas Albinus, Kurt Thaxton, Extractable and Leachable Analysis of IV Bag Systems using Direct Thermal Extraction of Materials and Stir Bar Sorptive Extraction of Aqueous Solutions coupled with Thermal Desorption Gas-Chromatography with Unit Mass and High Resolution Mass Spectrometric Detection, GERSTEL AppNote 02/2015 (www.gerstel.com/pdf/p-gc-an-2015-02.pdf)

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