In case of dissolution test, if there is variation within 6
individual units however the batch is complying as per S1
criteria, is it necessary to do investigation for the same?
What should be the criteria for such variation?

In case of dissolution test, if there is variation within 6 individual units however the batch is c..

Answer / sasikumar.r

Not necessaty to investigate.....
As per USP Acceptance Criteria for
S1 is 6 Each unit is not less than Q + 5%.
If individual values passes the Q+5% means, that batch passes the dissolution..

Is This Answer Correct ?    3 Yes 0 No

Post New Answer

More Analytical Chemistry Interview Questions

why we use Dichlorobenzene.nitrobezine.t-butyldi sulhate.for calibration of gc Head space

0 Answers   Raks Pharma,

A new drug substance found fail to meet specification for an unknown Impurity during stability study(Specific change),how would further proceed?

2 Answers  

What is the reason for negative peak in HPLC while using UV detector.

2 Answers  

How to determine water content of thioanisole? which interfere by KF titration?

1 Answers  

how can we determine RRF value in HPLC FOR CALCULATION OF IMPURITY ?

4 Answers   Macleods,

What is the difference between low pressure gredient and high pressure gredient in hplc instrument?

4 Answers  

Why we compare unequal concentrated solutions in heavy metals test. For example comparing the test solution with 1 ppm lead standard and telling it's less than 20ppm?

1 Answers   Micro Labs, Mistair,

Why we have to use KBr pellet technology ?

1 Answers  

how many types of Proceing methods?

7 Answers   Reddy Labs,

why we can use only 4 and 7 and 9 buffers in pH calibration

1 Answers   Cipla, Chola,

why we should take dst factor for below 1%moisture samples

0 Answers   Ind Swift Laboratories,

In Related Substances Test how we can reside the limit of impurity ?

2 Answers   MSN Pharma,

  • Organic Chemistry Interview Questions Organic Chemistry (288)
  • Inorganic Chemistry Interview Questions Inorganic Chemistry (113)
  • Analytical Chemistry Interview Questions Analytical Chemistry (1222)
  • Physical Chemistry Interview Questions Physical Chemistry (62)
  • General Chemistry Interview Questions General Chemistry (300)
  • Chemistry AllOther Interview Questions Chemistry AllOther (77)