News & events

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

In the upcoming version of USP <797> Pharmaceutical Compounding – Sterile Preparations, the method of sterilization has a significant impact on the maximum allowable Beyond-Use date (BUD) a compounded preparation may be assigned. The two approaches to sterilization in the chapter are aseptic processing and terminal sterilization.

USP 797 states “CSPs administered epidurally should have the same endotoxin limit as that of intrathecally administered CSPs.” This new requirement lowers the endotoxin limit for epidural products from parenteral limit calculations to intrathecal limit calculations.

Pyrogens are a group of fever causing substances which can be found in compounded sterile preparations (CSPs) if appropriate actions are not taken to reduce or remove them. One of the most widely known groups of pyrogens are bacterial endotoxins.