What are closely monitor parameters in stability study?
Answer / manoj tiwari
At the time of ANDA submission stability protocol submit and in protocol we include test parameters which shall be performed at withdrawn point.
Generally critical test parameters like Appearance,Water,one Id test, Dissolution,Assay and RS test performed.
| Is This Answer Correct ? | 1 Yes | 0 No |
how the qualification of pharma can help in banking
0 Answers Banking, Reddy Labs,
Why we use basket in place of bowl in dissolution apparatus
why temparature limit is +/-2 degrees and rh +/-5% in stablity
what is the significant achievement in your life
How to select HPLC column for a particular product?
what is limit of cleaning validation
You have been allotted a territory and given a list of physicians. How would you start calling?
why we study matrixing in stability system in stability study and on what basis we select time point.
What is the difference between Analytical method validation and Analytical method transfer?
what do you mean by bracketing and matrixing in stability
which is universal base for making suppositories?
why we are using toluene in resolution in UV calibration