Quality Control — Disintegration and Dissolution Standards
To ensure therapeutic efficacy, all capsules in Italy must pass Italian Pharmacopoeia and EU standards ($Ph. Eur.$):
Disintegration Test: Capsules must break down in a $37°C$ medium within 15 minutes.
Dissolution Test: This measures how quickly the active ingredient is released. If the shell material interferes with the chemical assay, "blank" shell values are subtracted to ensure the drug’s potency is accurately recorded.
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