which are the guidelines for force degradation studies?
Answer / 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 |
Whya the need of Specificity to do in Analytical Method Validation ?
Why do we use 500ppb sucrose and 500ppb 1,4 benzoquinone in TOC calibration?
pda detector mechanism?
1 Answers DKR, Teva Pharmaceuticals,
What is zero water in TOC Analysis?
In Karl fischer titrator what medium we can choose to analysing aldehyde and ketone samples by using KF reagent
how require to fix the linearity and accuracy cincentration range?
what is the need of calulation of RRF of impurity in HPLC analysis?
Why are using in Hi,zero air, Ni gass are used GC
5 Answers Aurobindo, ELBS, Vimta Labs,
What is cut off value of solvent used in hplc
WHAT IS DIFFERENCE BETWEEN RRT AND RRF IN HPLC
what does optical rotation and specific rotataion means,difference between them
Can any one tell what is RECALL OF PROCEDURES is