Tablet friability inspection method
First, the operation method
1. Commissioning of tablet friability tester: Before the test, the speed of the instrument should be adjusted to 25 rpm ± 1 rpm, and the test time is set to 4 min, that is, the total number of rotations of the cylinder is 100 times.
2. Dosage of the test sample: Take several pieces of the test piece for each test to make the total weight of about 6.5g; the average piece is larger than 0.65g of the test piece, and take 10 pieces of the sample for testing.
Second, the inspection method
1. Take the weighing bottle and accurately weigh the weight; then take the sample according to the amount of 3.2 to blow off the surface powder with a hair dryer, place it in the weighing bottle, and accurately weigh it. The difference between the two weighings is the weight of the test piece.
2. The test piece after weighing the above weight is placed in a cylinder, and the motor is rotated 100 times.
3. After the test is completed, the test sample shall be taken out for inspection, and the test sample shall not be cracked, cracked or pulverized.
4. Take the test sample after the test, and then blow off the powder with a hair dryer, place the above-mentioned weighing bottle in the weighing bottle, and accurately weigh it. The difference between the two weighings is the test sample loss after the test. the weight of.
Third, matters needing attention
1. Due to the shape or size of the test piece, when the tablet forms irregular rolling in the cylinder, the base of the instrument can be adjusted so as to be at an angle of about 10o with the horizontal plane (left and right) to ensure the test piece. The agent no longer gathers and can fall smoothly.
2. For moisture-absorbing tablets, the relative humidity of the laboratory should be controlled below 40%.
3. Tablets that form severe irregular rolling or special process production in the cylinder for shape or size are not suitable for this method and may not be subjected to friability inspection.
Fourth, record and calculation
1. Record the model of the instrument used, record each weighing data, and record the number of broken, cracked or pulverized pieces after the test.
2. Determine the weight of the test sample before and after the test, determine the weight of the test product after the test is lost, and determine the percentage of the weight loss of the test sample before the test.
V. Results and judgment
1. If no break, crack or comminuted piece is detected, and the weight loss is less than 1%, it is judged to be in compliance with the regulations.
2. If the weight loss exceeds 1%, but the test piece of crack, crack or smashed piece is not detected, the test sample should be taken again for 2 times. When the average weight loss of the three times did not exceed 1%, the crack was detected at the end, and the crack or the pulverized piece was judged to be in compliance with the regulations. When the average weight loss of the three times exceeded 1%, it was judged to be inconsistent with the regulations.
3. If the test piece of crack, crack or smashed piece is detected, it is judged to be inconsistent with the regulations.