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

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