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. 2022 Apr 5;26:12. doi: 10.1186/s40824-022-00258-6

Table 4.

Criteria of acceptance for the pyrogenicity test

Number of rabbits Product passes if the summary response does not exceed The product fails if the summary response exceeds
3 1.15 °C 2.65 °C
6 2.80 °C 4.30 °C
9 4.45 °C 5.95 °C
12 6.60 °C 6.60 °C