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?
- 2 Answers
- 4382 Views
- I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
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 |
Answer / b.kishan reddy
Dear @Shasikumr %RSD Should be match for the 6 Units. Generally it is 5%.
| Is This Answer Correct ? | 0 Yes | 0 No |
what is mean by least count balance?
What are the primary standards?
in HPLC injection volume is increase ,R.T will increase ?
5 Answers Claris Lifesciences,
what is peak purity? how may types of methods to determine peak purity?
what is the structure of DOWEX-50
what is the value of pH
why equlirium conatant of water have 14 value
if the purity is 99.9%,is need to do assay?
what is the difference between the ordinary loss on drying technique and vacuum oven technique?
India is. Under which zone as per QF1.?
4 Answers Acebright, Aurobindo, Gland Pharma,
In the method validation proceedure,lod & loq calculation we use the formulae for LOD=3.3*SD/slope and for LOQ=10*SD/slope,why we use 3.3 & 10 in the formulae?
As per USP u/vacuum means (how much vacuum should be applied)?
Organic Chemistry 
