A parenteral product is declared pyrogenic when the temperature rise in rabbits exceeds 1.4 °C in the 9 readings of 3 rabbits.

A parenteral product is declared pyrogenic when the temperature rise in rabbits exceeds 1.4 °C in the 9 readings of 3 rabbits.

• A. Less than 1.4 °C in 9 readings
• B. 0.6 °C in 9 readings
• C. All of the above
• D. > 1.4 °C in 9 readings

Answer: (D)

In the rabbit pyrogen test, you inject the product into three rabbits and monitor their temperatures over a set period, then look at the total fever response across all readings. The standard criterion is that the batch is considered pyrogenic if the sum of the temperature rises in the three rabbits exceeds 1.4°C. Since the measurement described involves the nine readings from the three animals, the crucial point is whether that total rise is greater than 1.4°C. Therefore, the statement describing a rise greater than 1.4°C in the 9 readings best matches the criterion. If the total is less than or equal to 1.4°C, it would not be declared pyrogenic. The option indicating less than 1.4°C cannot be true for pyrogenicity, so a statement like “All of the above” isn’t correct.

In the rabbit pyrogen test, you inject the product into three rabbits and monitor their temperatures over a set period, then look at the total fever response across all readings. The standard criterion is that the batch is considered pyrogenic if the sum of the temperature rises in the three rabbits exceeds 1.4°C. Since the measurement described involves the nine readings from the three animals, the crucial point is whether that total rise is greater than 1.4°C. Therefore, the statement describing a rise greater than 1.4°C in the 9 readings best matches the criterion. If the total is less than or equal to 1.4°C, it would not be declared pyrogenic. The option indicating less than 1.4°C cannot be true for pyrogenicity, so a statement like “All of the above” isn’t correct.