Table 5.
Batch | Content of bacterial endotoxin (EU/mg) | Bacterial endotoxin limited value (EU/mg)a |
---|---|---|
1 | 0.067±0.013* | 2.272±0.064 |
2 | 0.042±0.009* | |
3 | 0.071±0.024* |
Notes: Data are presented as mean ± standard deviation.
The bacterial endotoxin limited value was evaluated following the formula L=K/M, where L is the bacterial endotoxin limited value (EU/mg), K is a threshold pyrogenic dose of endotoxin per kilogram of body weight, and M is equal to the maximum recommended bolus dose of product per kilogram of body weight.
P<0.05 compared with the bacterial endotoxin limited value.