Drug stability expiration dating

But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?

Cantrell called Roy Gerona, a University of California, San Francisco, researcher who specializes in analyzing chemicals.

About 8% alprostadil loss occurred in five days at room temperature; under refrigeration losses of about 6% and 11% occurred after 1 and 2 months, respectively.

Frozen at -20°C and -70°C, less than 5% loss of any of the drug components occurred in 6 months.

A beyond-use date of 6 months when stored frozen at -20°C and 1 month when stored refrigerated at 4°C is appropriate for batches of the injection that have passed sterility testing.

Room temperature exposure should be limited, and the vial should be returned to refrigeration as soon as possible.

Pharmacies across the country — in major medical centers and in neighborhood strip malls — routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.

Gerona and Cantrell, a pharmacist and toxicologist, knew that the term “expiration date” was a misnomer.

Cantrell called Roy Gerona, a University of California, San Francisco researcher who specializes in analyzing chemicals.The short, safe answer is a simple “no.” However the truth of the matter is much more intricate, a lot more interesting, and requires a bit of knowledge about the Food and Drug Administration (FDA).In the late 1970s, the FDA first began requiring expiration dates on both prescription and over-the-counter medications.“To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing,” reads the agency’s regulation.Chemical stability testing was performed using stability-indicating high-performance liquid chromatographic analysis.Alprostadil was the least stable of the drug components at room temperature and under refrigeration.

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