Answer Posted / ganesh patil
the method is stability indicating method to prove in
forced degradation study.
In forced degradation method check impurity is well
separated or do not merge the impurity & drug will be pure
match factor limit above 950
| Is This Answer Correct ? | 9 Yes | 2 No |
Post New Answer View All Answers
If inhouse hplc related substance method is completly diffrent from Usp for finished proďuct with diffrent impurities then how require to prove method equivalecy?
WHAT IS THE PARAMETER FOR THE SELECTION OF MOBILE PHASE IN HPLC?
what parameters we will consider while developing a HPLC method and how we confirm our HPLC method is valid?
What is stray light in uv what are units for stray light
how to qualify the impurity?
What is the accrptance criteria in RSD for RS method precision on basis of impurity percentages?
in which situation require to change rs specification?
we are performed SOR for a particular product the limit is -6 to -10.We face particular bathes it is not meeting the specification.we performed diffrent instrument diffrent analyst we are getting diffrent diffrent results.solvent is dimethyl sulfoxide what could be the reasion
[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?
what is procedure of actual procedure for registration of drug?
acceptance criteria for lod & loq by standard deviation of response and slope??
identification is for unknown? qualification for known? reporting for LOQ?
A ha tc is actual defination of retention time?
If we do accuracy at same concentration at which linearity planned,what is the need to do linearity separately?
Colorimtry