Why do we do Mass Balance in Forced Degradation
My question is although we know impurity profile in Control condition of RS and Assay and as well as Forced Degradation condition.
What is the purpose of Calculating Mass Balance and What is its significance.
Explain with Formulae and Examples
Replies to this topic (1)
Hi sir
I will give this answer in an understandable manner
So first of all, Forced degradation is done to know the Impurity profile and behaviour of your drug molecule or drug product under stress conditions
For Example
You have a Drug product, and in the Control condition, you got an Assay of 99.8% and 0.2% of impurities. For forced degradation, you used the same product that you used for degradation, and the Assay is 93.0% and Impurities are 7%
It says that your product is degraded and is from the Control condition, and the Original Assay and Impurities shall be nullified by considering it as 100%
That means, the actual degradation for the condition is 7%-0.2% and is only 6.8%
So, to know the actual degradation, we should calculate the Forced condition with the Control condition to know the actual degradation. Thereby, we will be able to calculate the actual Degradation.
I hope you understand my explanation