I have a small query and I would be glad if you could answer it. I would like to know, is there any official document/guidelines, they may be by the FDA or any other regulatory authority, which states about the minimummass balance you have to achieve during forced degradation studies.
No guidance. Mass balance helps you ensure aboiut the "quality" of the degradation that was performed.
Perform sressed samples(Solution stress and Solid Stress) and non stress sample by HPLC decradation products (RC) method.
Calculate,
1) Calculate Assay of active remaining in both stressed and non stressed samples by RC method against reference standard.
2)Calculate the total % found in both the samples.
Mass Balance =Total % found in stressed samples/ Total % found in non- stressed SamplesX100
Total % Found= % Active Remaining+% of Known RC's + % of unknown
None as I recall. No mass balance is 100% since we don't count the water produced as an example. Thus, 85% is acceptable if it can be justified scientifically.
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