which procedure we follow if 6th month of accelerated sample fail?
Answer Posted / phani kumar
If long term studies are conducted at 25°/60%RH, and significant changed occurs at any time during 6 months, testing at the accelerated storage condition, additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria. Testing at the intermediate storage condition should include all test, unless otherwise justified.
Is This Answer Correct ? | 3 Yes | 0 No |
Post New Answer View All Answers
Loss of linearity in tkn analysis, possible reasons?
iam usig ph buffers merk. manually how to prepare ?
what is %labelled amount in content uniformity of dosage unit and its calculation?
Why use only methanol,used determinationof moisture content not use other solvents
As per ICH related substances stability trend limit from initial to shelf life
how much mass should be there in volumetric flask while in preparation of sample for assay?
WHY given much noise PDA dector then VWD Dector
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
What is the diffrence in japan mkt requirement in analytical method validation over US?
is it necessary to do HPLC calibration at wavelength 315nm if we are doing analysis at this wavelangth
in each media we require to use SLS? how to proceed?
In rs method development when we are going area normalization method to dilute standard method?
if you get peak in blank then what require to do?
If we have 5 strength which is not dose proportinate and excipients also diffrent in each strength then how we can proceed for Force degradation? and excipient are same but not dose propotinate the how FD?
What is dose dumping? why require to do?