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The drug substance stability profile is important.
Pheniramine maleate, an ocular antihistamine, was used as the model drug substance.
Currently there is no precedent for a BCS 2 drug substance to be granted a biowaiver.
Monitor the impurity in the drug substance with acceptance criteria ≤ acceptable limit.
The maximum allowed level of impurities in the drug substance is an important consideration.
1. Monitor the impurity in the drug substance with acceptance criteria ≤ acceptable limit 2.
Typically the drug substance attribute (assay) is used in formulating the batch during manufacture.
In the method for DTPA, the active drug substance, ipilimumab, was eluted in the void.
More specifics on equipment detail are provided in final dosage form and drug substance white papers.
The major limitation in designing of these dosage forms is unpleasant taste of the drug substance.
Seven impurities in agomelatine drug substance were determined by a newly developed RP-HPLC method.
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