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Antimicrobial preservatives are excipients added to aqueous pharmaceutical products. Nonsterile dosage forms may have preservatives added to protect them from the growth of microorganisms inadvertently introduced during or after the compounding process.

The Food and Drug Administration (FDA) requires dissolution testing to ensure continuous drug product quality and performance of controlled-release and extended-release products. This testing is performed during product development, batch release, and stability studies to verify that the release rate of the active pharmaceutical ingredient meets established specifications. Variability in release rates between batches can