Analysis of Thermal Extracts from an Eye Drop Container via the Trapped Headspace (THS) Method

User Benefits

- With more than 20 times the sensitivity of static headspace (SHS) analysis, this system can detect extracts from pharmaceutical packaging with high sensitivity. - With an electronic cooling trap, the system can analyze everything from low to high boiling point compounds in a single analysis cycle. - The system can also switch between trap mode and loop mode, depending on the concentration.

Introduction

Compounds eluted from pharmaceutical packaging are transferred to the pharmaceuticals, and the ensuing risk to humans from continuous exposure is a focus of interest. These substances are referred to as extractables and leachables, which together are abbreviated as E&L. Methods for measuring them are being sought at present, and various suggestions have been proposed. When screening for volatile and semi-volatile compounds, high sensitivity results are comparatively easy to obtain with the combination of GCMS and the trapped headspace (THS) method, which is why it is a focus of interest. The HS-20 NX Trap is a trap headspace sampler equipped with an electronic cooling trap. It is optimal for thermal extraction as it can be heated up to 300 °C. In trap mode, which uses the trapped headspace (THS) method, basically the entire volume of the headspace is concentrated into the trap. As a result, in comparison with loop mode, which uses the static headspace (SHS) method, more than 20 times the sensitivity is obtained with THS, which approaches the sensitivity of thermal desorption (TD). This articles introduces a comparison of the measurement results for thermal extracts from an eye drop container using SHS, THS, and TD.

September 24, 2021 GMT