The Hardness Test (Manual Tester)
With this equipment, the value shown on the scale needs to be multiplied by 9.81 in order to convert it into Newtons. One advantage of the manual tester is that it is obvious when the tablet has broken. Dissolution
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The Hardness Test (Electronic Tester)
The electronic display shows the breaking force in Newtons so no need for conversion. The BP doesn’t give limits for the Hardness test. These are set by the tablet manufacturers and they depend upon factors such as how hard the tablets need to be in order to withstand the company’s automated packaging equipment. Typical values would be: Mean Breaking Force > 60.0 N Standard Deviation < 5.0 N Both of these criteria would need to be met in order to pass the test. |
Friability
✅If the weight loss is less than 1% the tablets pass the test. ❌If the weight loss is more than 1% or there are any cracked or broken tablets the test fails. ❌If the test failed, it must be repeated again, if it failed the 2nd time its reported as fail. ✅If it passed the 2nd time, it has to be repeated one more time to decide if it’s a pass or fail. |
Uniformity of Mass
Criteria for passing the test: No more than 2 tablets are outside this range No tablet is more than 10% different from the mean. Both of these criteria must be met for passing the test. Disintegration
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Tablet Manufacture Cheat Sheet by MJC3
Tablet Manufacture: Hardness, Friability, Uniformity of Mass.
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