医薬品中の残留溶媒分析③

Residual Solvent, USP 467 Class 2 MixA

  • 医薬GC残留溶媒
  • GLC Application

医薬品中の残留溶媒分析③

1: Methanol 2: Acetonitrile 3: Methylene chloride 4: trans-1,2-Dichloroethylene 5: cis-1,2- Dichloroethylene
6: Tetrahydrofuran 7: Cyclohexane 8: Methylcyclohexane 9: 1,4-Dioxane 10: Toluene
11: Chlorobenzene 12: Ethylbenzene 13: m,p-Xylene 14: o-Xylene 15: Cumene

GC 分析条件

Model Nexis GC-2030 Linear Velocity 35 cm/sec
Detector FID-2030 Detector Temperature 250℃
Headspace Sampler HS-20 FID H2 Flow Rate 40 mL/min
Column SH-I-624 Sil MS (0.32 mm I.D.×30 m, d.f. = 1.8 μm) FID Make up Flow Rate 30 mL/min (He)
Column Temperature 40 °C (20 min) ‒ 10 °C/min ‒ 240 °C (20 min) Total 60 min FID Air Flow Rate 400 mL/min
Injection Mode Split 1:5 Injection Volume 1 mL
Carrier Gas Controller 線速度 (He)

HS-20 分析条件

Oven Temperature 80℃ Vial Volume 20 mL Vial Pressure 75 kPa
Sample Line Temperature 110℃ Vial Heat-retention Time 60 min Loading Time 1 min
Transfer Line Temperature 120℃ Vial Pressurization Time 1 min Needle Flush Time 5 min
Vial Stirring Off

【出典】株式会社島津製作所SHシリーズアプリデータ集 (株式会社島津ジーエルシー発行)

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