Table 2.
Experimental conditions referring to temperature recording in the rabbit pyrogen test (RPT).
| Experimental | IP | USP | JP | EP |
|---|---|---|---|---|
| Test room | Housing area or similar separate room | Separate area designated solely for pyrogen testing | Separate room | Housing area or separate room (at least 18h of previous staying) |
| Room T | Similar to the housing T | Similar to the housing T | Similar to the housing T | Within 3 °C of the housing T |
| Instrument | Accurate thermometer or T-recording device | Accurate T-sensing device (clinical thermometer or thermistor probe) | Rectal thermometer or T-measuring apparatus | Thermometer or electrical device |
| Precision | 0.1 °C | ± 0.1 °C | ≤ ± 0.1 °C | 0.1 °C |
| Time | Sufficient to reach a maximum T | Sufficient to reach a maximum T and < 5 min | - | An electrical device may be left throughout the test. |
| Site and depth | Rectum, ≈ 6 cm | Rectum, ≥ 7.5 cm | Rectum, 6–9 cm constant | Rectum, ≈ 5 cm constant |
| Restraint | By a loosely fitting neck stock | With lightly fitting neck stock | By a loosely fitting neck stock | By a loosely fitting neck stock (at least 1h before and throughout the test) |
| Posture | Natural resting | Natural resting | Natural resting | Normal |
| Feeding | Not allowed (2h before and during test) | Not allowed | Not allowed (several hours before and during test) | Not allowed (previous overnight and during test) |
| Watering | Allowed | Allowed, may be restricted | - | Not allowed |
T: temperature; IP: International Pharmacopoeia; USP: United States Pharmacopoeia; JP: Japanese Pharmacopoeia; EP: European Pharmacopoeia.