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How to prepare working sample of dosage unit (e.g. drug and excipients) with biorelevant medium to check interference

Three steps are required to prepare the working sample of dosage unit;

1. Prepare Primary Sample of Dosage Unit (PSD)

Crush dosage units and transfer the appropriate amount (prepare same concentration as PS) into volumetric flask and add organic solvent to dissolve the drug.

2. Prepare Secondary Sample of Dosage Unit (SSD)

By diluting the appropriate volume of centrifuged (to remove insoluble excipients) PSD with diluent to prepare a sample with the same drug concentration as SS.

3. Prepare Working Sample of Dosage Unit (WSD)

Use biorelevant medium and diluent (optionally) to prepare the WSD by diluting the SSD (which will have the drug concentration approximate 100%).

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