why we are using 6 dosage units in dissolution, and why we
are using 6 tablets in disintegation test.is there any
scientific reason beyond 6?

Answer Posted / madan joshi

The use of six dosage units as the basic sample size in
dissolution is partially due to the configuration of the
dissolution test assembly with six positions. However, in
some statistical procedures such as the estimation of a
confidence interval for precision of a measurement, a
sample size of six represents the point of diminishing
returns where the decrease in the confidence interval from
5 units is significantly greater than the decrease from 6
to 7 units. Thus the added value of obtaining additional
measurements is significantly less once six measurements
have been acquired.

Is This Answer Correct ?    6 Yes 38 No



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

If inhouse hplc related substance method is completly diffrent from Usp for finished proďuct with diffrent impurities then how require to prove method equivalecy?

316


in which situation ion pair require to use?

281


how you start RS method development when for new product?

292


how pda detector works over uv?

297


What if impurity area in control sample coming more as compared to LOQ level of impurity ?

1148






Loss of linearity in tkn analysis, possible reasons?

804


what parameters we will consider while developing a HPLC method and how we confirm our HPLC method is valid?

3109


What is the calibration of uv process and preparation

1510




1821


in api coa contains only process impurities and in product coa contains degradation impurities?

324


In BP2013, Loperamid HCl monograph. Assay by titration with 0.1N sodium hydroxide using hydrocloric acid 0.01N and reading the volume added between the 2 points of inflexion. I have a question that if the diluent solvent is ethanol is certainly consumed a amount of volume of titrant, so this volume must be eliminated on the result calculation or not apart from first point which is subtracted above.

2613


how to calculate elemental impurities?

549


How do we fix the sample concentaryion in hplc method development?

671


Describe your field experience sample type collected,sample techniques,field measurements taken and equipment used?

2280


WHAT IS THE CRITERIA FOR SELECTION OF TIME OF DISSOLUTION AND THE MEDIUM OF DISSOLUTION?

2145