A new method has been announced by VUV Analytics, for residual solvent testing in pharmaceutical products and excipients that significantly reduces analysis time while improving testing throughput.
It allows the combination of various sample types into a single test. The gas chromatography – Vacuum Ultraviolet (GC-VUV) spectroscopy method reduces the GC separation time recommended by the Unites States Pharmacopeia (USP) Method 467 of 60 minutes to 8 minutes or less.
Due to the VUV spectroscopy’s capability to provide unambiguous compound identification and quantitation even when signals overlap, residual solvent classes typically run as separate tests that can be combined into a single GC run.
Organic solvents are used in the synthesis of Active Pharmaceutical Ingredients (APIs) and can contaminate drugs during packaging, storage, and transportation.
They account for 50-90% of the mass in typical pharmaceutical operation and present most of the process toxicity.
This new GC-VUV method ensures complete identification of any solvents remaining from synthesis while delivering faster time to results.
The GC-VUV method utilizes automated static headspace sampling capabilities delivered by GERSTEL, Inc.
The GERSTEL MultiPurpose Sampler (MPS) delivers optimal temperature and injection setting automation to ensure the most efficient delivery of residual solvent samples to the GC, and ultimately the VUV detector.
