Drug stability test chamber test duration and sampling period

The JJF1101-2003 Environmental Test Equipment Temperature and Humidity Calibration Specification specifies that the test duration is 30 min and the test data is recorded every 2 min. Considering that the stability test period of the drug preparation in the drug stability test chamber is long, the shortest period is also six months. In just 30 minutes, it is not enough to verify the stability index of the drug stability test chamber, and the test time of 24 hours is in the actual test work. Some problems in the stability of the test chamber can be found, and these problems cannot be seen at all in the 30-minute test. We also conducted continuous testing for 72 hours, and the test results were almost identical to the 24h test results. Therefore, we set the test period of the drug stability test chamber to no load and full load for 24 hours (it can be extended if the pharmaceutical company does have demand), and the recording interval is still 2min mentioned in the calibration specification.

药品稳定性试验箱测试时长及采样周期

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