Interested to Buy Any Domain ? << Click Here >> for more details...
A new drug substance found fail to meet specification for
an unknown Impurity during stability study(Specific
change),how would further proceed?
- 2 Answers
- 7438 Views
- I also Faced
- E-Mail Answers
Answer Posted / chinna
if the sample failed in accelerated condition we go for long term storage condition.if it fails in long term stability we go for OOS and give to retest/Expiry as per ICH guideline
| Is This Answer Correct ? | 1 Yes | 0 No |
Post New Answer View All Answers
in each media we require to use SLS? how to proceed?
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.
Why we check moisture,ash & AIA in product
[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?
If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
What is the difference between chromatographic purity and related substances?
what is mean by ambient temperature?
What is the principle of Thermal conductivity detector and FID?
how to calibrate hplc & gc
How to determine water content of bis tetrazole amine mono ammonium salt
could negative ions be produced by bombardment process in mass spectrometry?
which situation gc hs and gc als require to use?
How to calculate coreletion coefficient
why we should take dst factor for below 1%moisture samples
what is the difference between potentiometric titration and karl fischer titration?
