Chapter 2.3. CONFIRMATORY METHODS FOR ORGANIC RESIDUES AND CONTAMINANTS
United Kingdom
Confirmatory methods for organic residues or contaminants shall provide information on the chemical structure of the analyte. Consequently methods based only on chromatographic analysis without the use of spectrometric detection are not suitable on their own for use as confirmatory methods. However, if a single technique lacks sufficient specificity, the desired specificity shall be achieved by analytical procedures consisting of suitable combinations of clean-up, chromatographic separation(s) and spectrometric detection.
The following methods or method combinations are considered suitable for the identification of organic residues or contaminants for the substance groups indicated:
Table 1
Suitable confirmatory methods for organic residues or contaminants
| Measuring technique | Substances Annex 1 96/23/EC | Limitations |
|---|---|---|
| LC or GC with mass-spectrometric detection | Groups A and B | Only if following either an on-line or an off-line chromatographic separation |
| Only if full scan techniques are used or using atleast3 (group B) or 4 (group A) identification points for techniques that do not record the full mass spectra | ||
| LC or GC with IR spectrometric detection | Groups A and B | Specific requirements for absorption in IR spectrometry have to be met |
| LC-full-scan DAD | Group B | Specific requirements for absorption in UV spectrometry have to be met |
| LC -fluorescence | Group B | Only for molecules that exhibit native fluorescence and to molecules that exhibit fluorescence after either transformation or derivatisation |
| 2-D TLC - full-scan UV/VIS | Group B | Two-dimensional HPTLC and co-chromatography are mandatory |
| GC-Elektron capture detection | Group B | Only if two columns of different polarity are used |
| LC-immunogram | Group B | Only if at least two different chromatographic systems or a second, independent detection method are used |
| LC-UV/VIS (single wavelength) | Group B | Only if at least two different chromatographic systems or second, independent detection method are used. |
- 2.3.1Common performance criteria and requirements
- 2.3.2Additional performance criteria and other requirements for quantitative methods of analysis
- 2.3.2.1Trueness of quantitative methods
- 2.3.2.2Precision of quantitative methods
- 2.3.3Performance criteria and other requirements for mass spectrometric detection
- 2.3.3.1Chromatographic separation
- 2.3.3.2Mass spectrometric detection
- 2.3.4Performance criteria and other requirements for chromatography coupled to infrared detection
- 2.3.4.1Infra-red detection
- 2.3.4.2Interpretation of infra-red spectral data
- 2.3.5Performance criteria and other requirements for the determination of an analyte using LC with other detection techniques
- 2.3.5.1Chromatographic separation
- 2.3.5.2Full-scan UV/VIS detection
- 2.3.5.3Performance criteria for fluorimetric detection
- 2.3.5.4Performance criteria for the determination of an analyte by an LC-immunogram
- 2.3.5.5Determination of an analyte using LC with UV/VIS detection (single wavelength)
- 2.3.6Performance criteria and other requirements for the determination of an analyte by 2-D TLC coupled to full-scan UV/VIS spectrometric detection
- 2.3.7Performance criteria and requirements for the determination of an analyte by GC in combination with electron capture detection (ECD)