Why forced Digradition Study is done
Answers were Sorted based on User's Feedback
Answer / umesh patel
the forced degradation study is carried out for
1. to determine recommonded storage conditions
2. to characterize possible impurities formed under various
stress conditions
3. to validate the stability indicating nature of the
method in place
4. to support stability data package submitted to
regulatory agencies
| Is This Answer Correct ? | 36 Yes | 1 No |
Answer / ganesh patil
the method is stability indicating method to prove in
forced degradation study.
In forced degradation method check impurity is well
separated or do not merge the impurity & drug will be pure
match factor limit above 950
| Is This Answer Correct ? | 9 Yes | 2 No |
Answer / asha latha
Forced degradation is a process of exposing a compound under severe stress conditions to evaluate the capacity of compound in all the conditions and to check given method is stability indicating ( whether a degradation products are coming in our methodology)
| Is This Answer Correct ? | 2 Yes | 0 No |
Answer / chaitanya
It was performed in order to ensure that any degradants generated during storage and shipment will not influence the assay of the method or the peak of interest. This is the reason why we are to acquire 10 to 30% degradation and peak purity should be passed
| Is This Answer Correct ? | 2 Yes | 0 No |
How to choose concentration of LOQ solutions for RS analysis? Example.
1 Answers Abbott, Indoco Remedies,
What is the difference between Capillary column and Packed column.
7 Answers Cipla, Hetero, Sun Pharma, Supreme Petrochem,
what is the difference between the Purity and Potency of drug substance
1 Answers Divis Laboratories, Graviti Pharmaceuticals,
when we talk about change in entropy we consider total entropy means of surround +entropy of system but when we talk about change in Gibss free energy we consider entropy of system.explain with reason.
Why Urasil and Caffeine use for HPLC wavelength accuracy calibration. which is most suitable, Why? other than these which can be used?
column washing procedure for normal phase and reverse phase?
Why pyrene is also use for calibration if detector
how do you established the RRF for unknown impurity
What should be the calibration procedure for wavelength accuracy in case of HPLC?
How we performed the force degradation for drug substance, is any specific guideline is available for each parameter(Acidic, basic, oxidation,heat)? what conditions you mentained for above parameters.
what is the difference between melting range & melting point? Which is more significant?
how to set sample and standard concentration in RS method?