This application note describes a universal method for the analysis of residual solvents in pharmaceuticals using static headspace GC-FID/MS. The method is capable of analyzing more than 50 solvents in a single run. The method has been optimized for the three classes of residual solvents defined by the ICH, allowing for the qualitative and quantitative analysis of all three classes at appropriate concentrations.
This document presents a retention time locked GC/MS/FID method capable of analyzing over 50 solvents in a single run. The method is optimized to identify and quantify residual solvents across all three ICH classes at appropriate concentrations, addressing the need for broad dynamic range in pharmaceutical quality control.
The procedure details sample preparation using DMSO or DMSO/water, and specifies the instrument configuration including the Agilent G1888 Headspace Sampler, Agilent 7890 GC, and 5975 MSD. It highlights the use of a DB-1301 capillary column for separation and provides specific analysis parameters and SIM settings for the method. This manual is written in Japanese.
| Headspace Sampler | G1888 |
|---|---|
| GC Model | 7890A |
| MS Model | 5975 |
| Column | DB-1301 20mx0.18mmx2m |
| Injection Port Temperature | 250 C |
| Oven Final Temperature | 200 C |
| Transfer Line Temperature | 120 C |
The method can analyze 56 types of solvents in a single run.
The method covers all three classes of residual solvents defined by ICH guidelines.
The method uses DMSO or a DMSO/water (1:1) mixture to dissolve the drug substance.