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Potency estimates for candidate standard 12/188 stored at elevated temperatures for 7 months relative to ampoules stored at − 70 °C.
| Storage temperature | Potency relative to − 70 °C |
|||
|---|---|---|---|---|
| GM | 95% CI | GCV | n | |
| − 20 °C | 1.03 | 0.98–1.09 | 11.0 | 18 |
| + 20 °C | 1.03 | 0.98–1.09 | 10.9 | 18 |
| + 37 °C | 0.99 | 0.95–1.03 | 8.9 | 18 |
| + 45 °C | 1.05 | 1.01–1.09 | 8.3 | 18 |
GM — geometric mean.
CI — confidence interval.
GCV — geometric coefficient of variation (%).
n — number of estimates used in calculation.
