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Gas Chromatograph (GC) Gas Chromatograph (GC)
Solvent Residue 1 5 8
7
Residual solvents in pharmaceuticals are defined as volatile organic compounds used in or generated from the manufacture of drug 1:Hexane
substances, pharmaceutical additives, or drug products. They are strictly controlled according to risk classifications from Class 1 to Class 3, 2:Nitromethane
which are based on the risk to human health. 3:Chloroform
Headspace GC methods specified in the USP (U.S. Pharmacopeia), General Chapters <467> Residual Solvents, are commonly used for 4:1,2-Dimethoxyethane
analysis of residual solvents.Presented here is an analysis of residual solvents as described in USP<467> carried out with an HS-20 5:Trichloroethene
6:Pyridine
headspace sampler and a Shimadzu Nexis GC-2030 Gas Chromatograph. 3 7:Methylbutylketone
8:Tetraline
Analytical Conditions 6
Instrument :Nexis GC-2030 Headspace sampler :HS-20 2
Detector :FID-2030 Vial equilibration :60 min @ 80°C 4
Column :SH-Rxi-624 Sil MS (0.32 mm I.D. × 30 m, d.f. = 1.8 µm) Sample line temp :110°C
Carrier gas :Helium, 99.9995% purity Transfer line temp :120°C
Injection volume :1 mL Vial pressurization :1.00 min @ 75 kPa 5.0 10.0 15.0 20.0 25.0 30.0 35.0 min
Linear velocity :35 cm/s (constant linear velocity) Loading time :1 min
Injection mode :Split 1:5 Chromatogram of WATER-SOLUBLE ARTICLES Class 2B Standard Solution by Procedure A
Column temperature :40 °C (20 min) - 10 °C /min - 240 °C (20 min) Total 60 min
Detector temperature :250ºC
Shimadzu Gas Chromatograph Product Lineup
S/N ratio and Repeatability of Class1 Model Features
· Ideal for routine analysis in the R&D lab or industrial setting
No. Compounds S/N ratio %RSD (n=6) · Wide range of applications from capillary to packed column analysis
· Large GC oven accommodates up to 4 detectors and 2 injection ports
1 1,1-Dichloroethane 320 2.8 · With 7 heated zones and sixteen 24 volt relays, a perfect platform for our System GC program
2 1,1,1-Trichloroethane 220 2.3
3 Carbon tetrachloride 20 2.9
GC-2014
4 Benzene 170 2.5
5 1,2-Dichloroethane 60 3.4 · Flagship model
· Touch-panel interface, which features clear graphics that display information instantly whenever needed.
· High-sensitivity detectors support a wide variety of analyses
· Intelligent flow controller with exceptional reproducibility
· Advanced flow technology ensures seamless method transfer to GCMS
· Faster analysis with hydrogen carrier gas
· “Eco mode” to optimize the use of carrier gas such as helium and reduce electricity use when idle.
· Equipped with day and time programming, system self-check feature, automatic notification of when to
Nexis GC-2030 replace consumables.
· A choice of four inlets, six detectors, and specialized valve accessories enables configurations tailored to
fit the needs of laboratories.
Nexis GC-2030 + HS-20
Solutions for Palm Oil Analysis Application Notebook
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