1. 6 tabs placed in basket at 37 degrees 2. submerge in fluid 3. lift out after time specified in monograph 3. if some fail redo with 12 more 4. pass if more than 16 pass
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pass for suppositrries
components seperate and soluble dissolve
4 of 14
whta is dissolution
amount of drug that goes into solution per unit time
5 of 14
use of rotating basket/paddle?
1.place tabs in device 2. 37 degrees 50-100rpm speed
6 of 14
use of reiprocating cyclinder
1.place tab in internal cycliner and then in external cyclinder 2.device reciprocates up and down
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pass for immediate release tablet?
no less than 70% of active ingredient should dissolve
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uniformity of mass for tablets?prodcedure
indvidaly weigh 20 tabs, calculate average, if weigh more than 250mg no more than 5% deviation, if between 80-250 no more than 7.5% deviation, if weigh less than 80 mg no more than 10% deviation from average
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uniformity of mass test for capsules?
weigh intact, weigh just shell, calculate difference
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uniformity of mass for powder?
weigh whole container, empty wash with water and acid, weigh empy container, calculate difference
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offcial bp tests vs non offcial
dissolution, disintergration, uniformity of mass, uniformity of content vs friability and hardness
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friabilty?what is it? test?
measaure of mass loss from surface of tablet when in drum, gives idea of mass loss in transport. 1. weigh tabs up to 6.5g.2.place in drum and rotate 100 times at 25rpm3. dust off powder and reweigh tabs and calcuate difference 4, loss of mass no greater t
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hardness test?
place tabs between two jaws and apply force, record min max and mean newtons till tab breaks
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