Hello Everyone,
We are planning to take a Validation/Commercial Batch for a potent
drug with a dosage of 0.125 mg per tablet.
Assay of the API to be used in the batch is 100.2%.
I've seen in other products where the % Assay of API is less than 100
(lets say 98.8%), the total quantity of the API to be dispensed was
calculated to attain 100% of the Label Claim. The result will be
greater than the theoretical weight of the API required for the Batch.
In the PRESENT case where %Assay is Greater than 100% (LETS SAY
101.0%), should the quantity of the API to be dispensed be calculated
on 101.0% basis?In this case, the quantity of the API to be dispensed
will be less than the theoretical quantity of API required for the
batch.
In my opinion, even though the % Assay result is > 100% it should be
considered as 100%.
Waiting for your inputs in this regard and correct me if I am wrong.
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Anand G
anand_g11@yahoomail.com
AA
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