There was a discussion and it has been found that some experts from the pharmaceutical industry couldn't justify the numbers of tablets.
There was discussion on, Why the number six in dissolution why it it is five or seven? And maximum number of tablets for dissolution test.
Here we want to put forth on this magic number "SIX "
Six is statistically significant digit for any conclusion to be drawn from a random sampling. As we always try to use minimum quantity of samples and that should be statistically significant to prove the sampling is sufficient to represent the population (tablets)
SO, Six tablets is able to minimum tablet number which is sufficient to include the standard deviation (or variance) and the distribution of the population.
As per the pharmacopieal norms, there are three stages of dissolution testing to qualify the product in Dissolution test.
What is the maximum number of tablet necessary for Dissolution test?
Here, maximum is used as, even if the tablets fails on first two stages. Dissolution test has three stages as per the pharmacopial norms. As per the various stages, first stage includes six tablets , which when failed next six tablets are used and even if second stage fails, additional twelve tablets are used.
SO, altogether, Six plus six plus twelve is Twenty four tablets.
Hence 24 tablets is maximum tablets that can be able to qualify the product in dissolution test.
With Best regards
Pharmashastra team
follow our facebook page Pharmashastra
There was discussion on, Why the number six in dissolution why it it is five or seven? And maximum number of tablets for dissolution test.
Here we want to put forth on this magic number "SIX "
Six is statistically significant digit for any conclusion to be drawn from a random sampling. As we always try to use minimum quantity of samples and that should be statistically significant to prove the sampling is sufficient to represent the population (tablets)
SO, Six tablets is able to minimum tablet number which is sufficient to include the standard deviation (or variance) and the distribution of the population.
As per the pharmacopieal norms, there are three stages of dissolution testing to qualify the product in Dissolution test.
What is the maximum number of tablet necessary for Dissolution test?
Here, maximum is used as, even if the tablets fails on first two stages. Dissolution test has three stages as per the pharmacopial norms. As per the various stages, first stage includes six tablets , which when failed next six tablets are used and even if second stage fails, additional twelve tablets are used.
SO, altogether, Six plus six plus twelve is Twenty four tablets.
Hence 24 tablets is maximum tablets that can be able to qualify the product in dissolution test.
With Best regards
Pharmashastra team
follow our facebook page Pharmashastra
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Formulation