Page 7 - Shimadzu Nexera UC

Prevent degradation of labile compounds Only a few simple preparation steps for cleaning validation

With conventional solvent extraction, labile compounds may react with extraction solvents or could be oxidized and/or Nexera UC can be applied to cleaning validation which is performed in the pharmaceutical industry to confirm that manufactuaring
degraded. equipment has been properly cleaned. Nexera UC automatically runs a series of steps from extraction to analysis, by only putting the
sample swab in the extraction vessel. In conventional cleaning validation, the sample swab needs to be extracted with water, and
then the extraction is analyzed by TOC. However, when a target compound is hydrophobic, swab extraction is performed with
ethanol and TOC is not applicable. Nexera UC is capable of performing both types of cleaning validation.
Oxidized Coenzyme Q10 Easy to be
oxidized
Alkylbenzenesulfonates
Solvent Extraction-SFC
Reduced Oxidized
Coenzyme Q10 Coenzyme Q10
Reduced Coenzyme Q10
Sample for cleaning
validation

On-line SFE/SFC

0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 min Blank
Extraction and analysis of reduced coenzyme Q10 in supplements An extraction vessel enclosing sample swab
0.0 2.5 5.0 7.5 min
Extraction and analysis of a detergent-added swab
The sample is provided by Daiichi Sankyo Co., Ltd.

Analysis of biomarkers from dried blood spots (DBS) Supercritical fluid extraction of trace additives in polymers

Nexera UC can extract a trace amount of liquid samples. For biomarker validation, the preparation requires simply enclosing a Polymer additives are widely used to prevent optical or thermal degradation, or to enhance functionalities. An example, Irganox 1010,
blood spot in the 0.2 mL special extraction vessel. is insoluble in THF or Chloroform, and hard to sublime. Therefore, analysis by GPC or GC is difficult. By simply homogenizing a sample
and enclosing it in the extraction vessel, Nexera UC can detect labile or trace quantities of additives.

Peaks Soxhlet extraction Extraction by Nexera UC
1. Phosphatidyl Choline
2. Lyso Phosphatidyl Choline
1 3. Phosphatidyl Ethanolamine
4. Lyso Phosphatidyl Ethanolamine Irganox 1010
5. Phosphatidyl Glycerol Blood spots on DBS
6. Phosphatidyl Inositol
2
3
4
5
6 Place sample directly
into extraction vessel
0 2.5 5.0 7.5 10.0 12.5 min 0.0 1.0 2.0 3.0 min
Extraction and analysis of phospholipid-added plasma on DBS Extraction and analysis of polymer additives in polyethylene
(Column: Shim-pack UC-X Diol) An extraction vessel for DBS About 8 to 24 hours reflux

Nexera UC
6 Supercritical Fluid Extraction/Chromatograph System 7