Pharmacopeial Method Qualification Options

Regulatory
1

If a Drug Product didn’t have a USP Monograph but one did exist in the EP, would the FDA accept an EP Method in a submission as long as it was appropriately qualified?

2

Hi Michael,

You can adopt EP method to claim in-house method and also check the all impurities mentioned in Drug substances are must elute in this method. also performed the degradation of drug product and check the mass balance. if mass balance are achieved so method are prove as a stability indication method and validate. you can submit this method to FDA as an in-house claim.

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3

Thank you. Can you elaborate on how to find Mass Balance?

4

Hi Michael,

Please find the below formula to calculate Mass Balance

                       **(Assay of degraded sample + total impurities generated)**

Mass Balance = -------------------------------------------------------------------------- X 100

(Assay of As Such sample + total impurities generated)

Condition % Assay %Total Impurities Mass Balance
Sample (As Such) 99.9 0.05 100.0
Sample acid degradation 100.2 0.40 100.7
Sample alkali degradation 87.7 13.61 101.4
Sample Peroxide oxidation degradation 100.4 0.12 100.6
Sample Thermal degradation 100.0 0.17 100.2
Sample UV degradation 100.1 0.05 100.2
Sample Sunlight degradation 99.6 0.05 99.7

Mass balance must be complies between 95 % and 105%

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