Research Article
A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients
Table 4
Comparison between the methods used to determine formaldehyde in excipients or drug substances.
| Analytical technique | Derivatization and/or extraction times (min) | Run time (min) | Approx. recovery (%) | Approx. precisiona (%) | Approx. LODb (ppm) | Ref. |
| GC-FID | 5 | >7 | No data | No data | 7 | [21] | GC-MS | 240 | 15 | 86–99 | 3.7 | 0.02 | [19] | SHS-GC-FID | 30 | 5 | 85–97 | ≤3 | 0.05 | [20] | SHS-GC-MS | 20 | 28 | No data | 3.1 | 0.05 | [20] | SPME-HS-GC-MSc | 60 | 22.5 | 106.5–113.5 | 3.13–13.19 | No data | [18] | HPLC-UV | No data | ≥35 | 84–97 | 0.5–1.2 | 0.5 | [22] | HPLC-UV | 60 | 30 | No data | No data | 0.03 | [15] | HPLC-UV | No data | No data | 94.9–102.9 | No data | 10 | [23] | Proposed method | 15 or 25 | 11 | 87.8–104.3 | 0.75–3.6 | 2.44 | — |
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aIncluding inter- and intraday precision; bLOD in sample; cSPME: solid-phase microextraction.
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