I understand that the tests are carried out as per the method developed and validated. But why is 500ml sufficient to evaluate Salbutamol tablets dissolution. Why did the innovator fix 500ml for the test. Why could it not have been the conventional 900ml?
Saeed Ayaz Khan
Strength of Salbutamol in tablet is about 2 mg tab and if you dissolve in 900 ml dissolution media then it's concentration is too low if you determine through HPLC or UV. Specific concentration is required for test and analysis that's why use 500 ml dissolution as media.
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Andrei Blasko
Most likely because of the dose. The lowest concentration that needs to be analyzed at early time points of dissolution should be within the limit of quantitation (LOQ) of the analytical method used to monitor the release.
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