Hello sir, in the last q2R1 guideline. In the dissolution test for SR dosage the limit was Q-20% of the lower limit. The example was 20%at 1st hour so we start from zero - and that was an issue - so, it's not clear for me the modification done at this point in the new R2 guideline So, please clarify what should be done for SR dosage for range. Thanks
Hello sir in dissolution testing you example about time point and there you mention 60% limit of dissolution . Acc. To Q-45% how you elaborate 60% to 25% if you said Q-45% is absolute
I was little bit confused till now, but this video has eliminate all confusion and doubts
Very Good work sir... please give more examples for better understanding for beginners also.....
nice explanation sir
One question is that how can we determine QL in dissolution testing for modified release dosage form
Can u explain the difference between working range and reportable range
You said 1st point disso release 60% at 10min. Then lower limit would be 15% not 25% sir.
Hello sir, in the last q2R1 guideline. In the dissolution test for SR dosage the limit was Q-20% of the lower limit. The example was 20%at 1st hour so we start from zero - and that was an issue - so, it's not clear for me the modification done at this point in the new R2 guideline So, please clarify what should be done for SR dosage for range. Thanks
MR: The range must be evaluated from LOQ to 120% of LC
Hello sir in dissolution testing you example about time point and there you mention 60% limit of dissolution . Acc. To Q-45% how you elaborate 60% to 25% if you said Q-45% is absolute
Sir please make a detail videos about preperative Hplc
Next part of ich ich Q2(R2) please