When variability in excipient quality is and isn’t acceptable

Regardless of whether it’s prescription or over-the-counter, the ingredients on a drug product label typically include one, maybe two, active pharmaceutical ingredients (APIs). The rest of the list is comprised of “inactive” ingredients (excipients) which in reality are far from inactive. Their functions range from helping to guarantee the stability and bioavailability of the API to the drug product’s manufacturability to its texture and taste. Because of the multiple roles they play in drug product formulations, excipient quality is as important as that of the API, so standards are needed to ensure their purity and reliability.

  • How can you, as a manufacturer, be confident in the quality of the excipients you get from your suppliers?
  • How can you, as a research scientist, be sure you’ll have the excipients you’ll need to formulate the new therapeutics you’re developing?
  • How can you, as a consumer, have confidence in the quality of the drugs you’re using or giving to your family?

Without quality standards, you can’t.

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For some products variability in quality is maybe acceptable, for excipients quality standards are necessary to ensure drug quality
excipients quality is critical

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