Stability and sterility testing and dating

The USP as well as local Boards of Pharmacy are concerned that compounded prescriptions are of correct potency and purity to accomplish their intended goal without doing harm.

Our experience has shown that despite correct formulation worksheets, accurate weighings and measurements, and documenting procedures, the preparations may still not be as intended.

The Exten DATE™ Sterility Testing system provides a convenient, simple, and inexpensive answer.

The revolutionary Exten DATE™ system allows hospital and clinical pharmacies to safely, accurately, and economically batch-compound CSPs between 40m L and 200m L in volume.

Our potency testing is most often carried out using Ultra High Performance Liquid Chromatography, the most advanced analytical technique available, and one which meets or exceeds regulatory requirements.

Stability Testing Stability testing is the testing of the entire package: active ingredient(s), excipients, and container.

The familiar "Expiration Date" terminology was replaced with "Beyond-use Date" (BUD).

low-, medium-, high-risk level CSPs) into two categories – Category 1 and Category 2 – based primarily on the conditions under which the preparations are made and the time within which they will be used.

The proposed beyond use dates (BUDs) for these categories limit the dating of Category CSPs to a maximum of 42 days even if stability studies and sterility testing are performed.

The maximum effective BUD allowed after the required standard sterility quarantine period is 28 days.

BUDs based on well-designed c GMP stability studies and sterility testing per (USP ) are sufficient to support extended BUDs up to at least 90 days.

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