gastro-rezistant tablet, dissolution formula, please help
Posted: Sun Mar 04, 2012 7:33 pm
Hello,
I don't understand how to write the formula at gastro-rezistant tablet dissolution.
In the specification the acceptance criteria is considered: 5%
The active substances in the product is 75 mg, average mass is 132,3.
The reference solution have 3.75 ppm.
The test solution (dissolution sample) is prepare: 1 gastro-rezistant tablet in 1000 ml medium(HCl 0,1 M) and then injecting in the chromatogram system.
If I write:
Area sample/Area reference substances* weight reference/ theoretical quantity of active substance (75 mg) * Purity of reference substances * .............then what?
Please be so kind and help me.
Thanx!
I don't understand how to write the formula at gastro-rezistant tablet dissolution.
In the specification the acceptance criteria is considered: 5%
The active substances in the product is 75 mg, average mass is 132,3.
The reference solution have 3.75 ppm.
The test solution (dissolution sample) is prepare: 1 gastro-rezistant tablet in 1000 ml medium(HCl 0,1 M) and then injecting in the chromatogram system.
If I write:
Area sample/Area reference substances* weight reference/ theoretical quantity of active substance (75 mg) * Purity of reference substances * .............then what?
Please be so kind and help me.
Thanx!
