Overview of Analyses for the Extractables Study
| Test Solution | Analyses | |||||
|---|---|---|---|---|---|---|
| HPLC-UV-MSa | GC-MS/FIDb | GC-MS/FID Derivatized | Headspace GC-MS/FIDc | ICP-MSd | TOCe | |
| 80% Ethanol | x | x | NPf | NP | x | NP |
| 1 M NaOH | x | x | x | x | x | x |
| 1 M HCl | x | x | NP | x | x | x |
| 1% Polysor-bate 80 | x | x | NP | x | x | NP |
| Typical Method Detection Limit Rangeg | 10–100 μg/L | 10–100 μg/L | 10–100 μg/L | 10–100 μg/L | 0.1–400 ppb | At least 0.5 ppm |
↵a HPLC-UV-MS: high-performance liquid chromatography with UV and mass spectrometry detection.
↵b GC-MS/FID: gas chromatography–mass spectrometry and flame ionization detection after concentration with sample concentration of 10× to 50×.
↵c Headspace GC-MS: headspace gas chromatography–mass spectrometry.
↵d ICP-MS: inductively coupled plasma mass spectrometry.
↵e TOC: total organic carbon.
↵f NP: not performed.
↵g Obtained from report of analysis.