which are the guidelines for force degradation studies?
Answer Posted / praveen kumar_ipca
The ANVISA forced degradation study requirements have an expansion of forced degradation beyond the work already performed during the various stages of drug and formulation development. This differs from the approaches adopted by ICH, EMA & FDA guidelines.
Praveen Kumar
IPCA
Sr.Excurive
| Is This Answer Correct ? | 0 Yes | 0 No |
Post New Answer View All Answers
What is the principle of Thermal conductivity detector and FID?
which one is better separation in high pressure liquide chromatogram orlowpressure chromato gram in hplc
what is procedure of actual procedure for registration of drug?
what is the principle involved in turbidometry and nephelometry ?
How will u perform degradation study in detectors other thann PDA in HPLC Methodology
Did anybody have method for acetyl cysteine effervescnce tablet
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 the different in Total ash, sulphated ash, acid insoluble ash, alcoholic or non alcoholic ash?
UV and PDA detector, which have less signal to noise ratio?
function of detecter in hplc ,gc and spectroscopy? function of carrier gas in gc?
why cone formation during dissolution?
What is Band broading effect explain
please explian me about area normalisation method,diluted standard method,impurity vs impurity and which one has to be selected in method development
How they found 1mL of K.F reagent is equivalent to 5mg of water and if we change the composition of K.F reagent, is it can neutralize more amount of water?
how require to set assay concentration for standard and sample?