Trung Son T.S.S.E Scientific Equipment & Tourist Joint Stock Company

Joint Stock Company

Trung Son T.S.S.E Scientific Equipment & Tourist Joint Stock Company is an Exclusive Distributor of SHIMADZU, a famous brand of analytical instruments, since 2000 in Viet Nam

Residual solvents in pharmaceuticals are classified from Class 1 to 3 based on their potential human health risk. Since these compounds are strictly controlled, highly sensitive analysis is required. Helium (He) is generally used as the carrier gas, but analysis using an alternative carrier gas such as N2 has also been in demand recently as He supply shortages have become an issue in recent years.
This article introduces a JP17 Supplement II-compliant analysis of water-insoluble samples for Class 1 and 2 residual solvents using N2 as the carrier gas Class 1 and 2 standard solutions were prepared and measured in accordance with Procedure A and B of JP17 Supplement II, using Shimadzu HS-20 headspace gas sampler connected to Nexis™ GC-2030 gas chromatograph. The two procedures differ in the type of column, the column temperature and the split ratio.
Column  Procedure A : SH-Rxi™-624 Sil MS (0.32 mm I.D. × 30 m, d.f.= 1.8 μm)
Procedure B SH-Stabilwax™ (0.32 mm I.D. × 30 m, d.f.= 0.25 μm)

Chromatogram of Class 2 Standard Solution by Procedure A (Water-Insoluble Sample)
 
Chromatogram of Class 2 Standard Solution by Procedure B (Water-Insoluble Sample)