A new drug substance found fail to meet specification for
an unknown Impurity during stability study(Specific
change),how would further proceed?
Answers were Sorted based on User's Feedback
Answer / vikas kumar
Firstly it was not clear on which condition we are getting
the OOS and at which time point.
It it was failed in Accelerated condition than we have to
look definately for intermediate condition for 12M.
if it was in long term condition than we have to firstly
raise the OOS and and proceed as per OOS procedure similary
we can check wether the method was stability indicating or
not.
Is This Answer Correct ? | 4 Yes | 1 No |
Answer / 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 |
In the test for control of absorbance in UV calibration why do we use only potassium dichromate and what is purpose of taking a specified amount of 57.0-63.0mg?
8 Answers Aurobindo, Cipla, FDC,
analytical method validation require to with respect to release specification or shelf life specification?
How to determine the EDTA content by potentiometry titration in Ceftriaxine sodium
is a bonded water molecule in an organic material can be easlisy and accuractly determined by KF rather than LOD
which effect is mainly responsible for chromatographic separation when silica is the statinary phase at TLC? thanks in advance
What is the purpose of octyl silane columns?
Related substance method equivalency on control sample or spiked sample?
If we are getting split peak in Chromatogram,what we can do?
what is turbidimetric titration?Give 2 examples.
why do we adjusted ph in the mobilphase
9 Answers Cipla, Dr Reddys, Reddy Labs,
In IR spectra, generally a molecule vibrates without apply emr or ir light?
why we use 0.1% acetone in gradient calibration of HPLC?
3 Answers Cipla, Dr Reddys, FDC,