Pharmaceutical Analysis Blog

Method for the analysis of residual solvents in pharmaceuticals

This application note describes a method for the analysis of Class 2 solvents (water-soluble samples) that are unsuited to Headspace GC methods.

Discover a method for the analysis of residual solvents in pharmaceuticals  >> 

Shimadzu_residual_solventsThe determination of residual solvents is crucial for the safety and quality of pharmaceuticals. The United States Pharmacopeia (USP) has classified these solvents into three main classes – Class 1, 2 and 3. Headspace gas chromatography testing methods have been employed for the determination of Class 1 and 2 residual solvents. However, there is no mention of methods for sub-group Class 2C solvents, which have higher boiling points and are not suited for headspace analysis.

In this application note, we describe a direct liquid injection method for the analysis of Class 2C residual solvents using the Nexis™ GC-2030 gas chromatograph. The results achieved resolution equivalent to residual solvents of other Class 2 solvents. Furthermore, the method demonstrated high repeatability in both Class 2C standard solutions (%RSD between 0.99 and 3.68) and a sample (headache medication) solution (%RSD between 0.29 and 4.00). The method also showed favourable recovery rate between 91% and 107%. This described direct liquid injection method proved to be suitable for the gas chromatographic analysis of Class 2C residual solvents in pharmaceuticals.

Shimadzu_g303_figure

Superimposed Chromatograms of Class 2C Standard Solution and Class 2A and 2B Standard Solutions.

Download this application note and...

  • Explore the use of Nexis™ GC-2030 for the direct liquid injection analysis of Class 2C solvents in pharmaceuticals
  • Compare the separation and analysis of Class 2A, 2B and 2C solvents using the same analytical method, conditions and gas chromatograph.

Discover a method for the analysis of residual solvents in pharmaceuticals  >> 

    

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