Analysis of Residual Solvents in Pharmaceuticals Using Headspace GC-FID/MS Detector Splitting System
Headspace gas chromatography with flame ionization detection (GC-FID) is often used for residual solvent testing of pharmaceuticals, though the qualitative power of this method is not particularly high. Because gas chromatography mass spectrometry (GC/MS) utilizes MS to perform qualitative analysis based on mass spectra, GC/MS can be used to estimate and identify individual peaks detected in the expected vicinity of a target solvent as well as other unknown peaks. We describe an example of residual solvent test of a pharmaceutical using a detector splitting system that simultaneously obtains FID and MS data in a single measurement.
- Content Type:
- Application
- Document Number:
- LAAN-A-MS-E038
- Product Type:
- Mass Spectrometry, Gas Chromatograph-Mass Spectrometry, Gas Chromatography
- Keywords:
- Residual solvent, Residual solvents in pharmaceuticals, JP17, USP467, EMA, ICH Q3C, Impurity, Pharmaceutical, Life Science, GCMS-QP2020, HS-20
- Language:
- English
- File Name:
- jpo216073.pdf
- File Size:
- 1,744kb