Residual solvents control is a mandatory test for active pharmaceutical ingredients. Column LION™ LN-1 provides fast, robust and reproducible separation for most commonly used solvents.
ABSTRACT
Head-space GC/FID method for the control of residual solvents in active pharmaceutical ingredients – methanol (CAS 67-57-1), ethanol (CAS 64-17-5), acetone (CAS 67-64-1), 1-propanol (CAS 71-23-8) and toluene (CAS 108-88-3) – on a LION™ LN-1 capillary column (50 m × 0.25 mm × 5 µm, LNI-5755-H150). Injection temperature 160 °C, helium carrier gas at constant pressure 60 kPa (40 ml/min), oven program 40 °C hold 0 min; 2 °C/min to 60 °C; 50 °C/min to 200 °C hold 5 min. Solvent dimethylsulfoxide, head-space oven 105 °C with 30 min heating, FID detection at 250 °C. All five solvents are resolved within about 14 minutes.
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MethanolCAS number 67-57-1
EthanolCAS number 64-17-5
AcetoneCAS number 67-64-1
1-PropanolCAS number 71-23-8
TolueneCAS number 108-88-3
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