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The core principle and regulatory requirements of the disintegration time limit meter
Date: 2025-12-04Read: 0

The core principle of the disintegration time limit meter is to simulate specific environmental conditions to monitor and accurately time the disintegration process of solid samples in real time, mainly involving the following key steps:

Environmental simulation and parameter controlThe instrument simulates the physical environment required for sample disintegration, such as temperature and motion frequency, through components such as a constant temperature bath and a reciprocating drive system. For example, the disintegrator used in drug testing needs to control the water bath temperature close to human body temperatureof37℃And ensure that the hanging basket moves up and down according to the prescribed frequency to comply with the requirements of standards such as the Chinese Pharmacopoeia.

崩解时限仪的核心原理与法规要求

Disintegration process monitoringPlace the sample in a basket with a sieve, and the instrument monitors the disintegration status of the sample through sensors or electrical conductivity. When the sample completely disintegrates and passes through the sieve, the system automatically records the time.

Data collection and feedbackThe disintegration signal collected by the sensor is transmitted in real-time to the control system, and the disintegration time limit is calculated after analysis. If the result exceeds the set threshold (such as blasting operations)useBJ-IIThe safety range of the disintegration time limit meter will be indicated to the operator through sound and light alarms.

Calibration standards and procedures:

Calibration conditionsEnvironmental temperature needs to be controlledIn10~35℃Relatively wetdegree≤85%, power supplyfor220±22VThe50Hz±0.5Hz.

Distance and frequency calibrationBy measuring the up and down movement distance of the suspended basket(3Take the average of the two values) and forwardreturn31Next time, calculate whether the actual error matchescombine, synthesize±2mmand±3%The requirements.

Timer and temperature calibration: Select quite a fewYu5Measure the timer error with a stopwatch at the minute calibration point; Temperature calibration needs to be stable at the set valuefixed0.5After an hourpartition3Minute measurementquantity3Ensure the temperature of the secondary water bath is within the allowable range of deviation.

Verification of indication errorUsing standard substances with disintegration time limits(asGBW(E)090143)Repeat testingquantity6Next, calculate the deviation between the average value and the standard value to ensure that the indication error meets the specifications.