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How to calculate mass balance in RS after degradation
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Answer / vicky
1. Perform assay(A1) of undegraded sample say lot x
2. Perform Assay(A2) and RS of Degraded sample of same lot x
3.Calculate mass balance as (A2+Total degradation)/A1*100
Ideally mass balance should be near to 100 but generally it wont be due to factors like non chromophoric impurity production or production of impurities with RRF below 0.8 or above 1.2 etc
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