which are the guidelines for force degradation studies?



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

Post New Answer

More Analytical Chemistry Interview Questions

how to calculate the Step and ripple accuracy for pump gradient test for UPLC?

1 Answers   Wockhardt,


In Analytical method development related substance method when did follow w/w method when did follow area normalisation method

5 Answers  


WHY pKa value is more important than pH value of the mobile phase in HPLC?

0 Answers  


if you have given a blank water how you analyse by general analytical techniques?

0 Answers  


Which std. used for standrdisation of ZnSO4?

1 Answers  






why we are use metthanol variously in kfr?why don't use other solutions?

4 Answers  


I want analyze my compound at 325 nm so which standard shall i use to calibrate my HPLC system? How i can assure my hplc detector is suitable or not?

3 Answers   AMRI,


why in uv we take k value less than 1

2 Answers  


Why dissolution test performed on six jar?

1 Answers   Mylan,


The boiling point of 1,3 butadiene is -4.4 DC & the boiling point of Pentane is 36.1 DC. Then how come Pentane elute before 1,3 BD in GC analysis?

1 Answers  


how to start the method development of Dissolution and related substances.

1 Answers   Apex,


What is the definition of RRF

2 Answers  


Categories
  • Organic Chemistry Interview Questions Organic Chemistry (342)
  • Inorganic Chemistry Interview Questions Inorganic Chemistry (123)
  • Analytical Chemistry Interview Questions Analytical Chemistry (1387)
  • Physical Chemistry Interview Questions Physical Chemistry (62)
  • General Chemistry Interview Questions General Chemistry (478)
  • Chemistry AllOther Interview Questions Chemistry AllOther (190)