Dating the pharmacist on a mpho mosala dating
Specifically, the lack of reference to extended BUD’s when stability/sterility literature references or method suitability studies have been performed.
Seems the revised BUD guidance gives some credence to preservatives, sterilization methods, etc, but with a maximum BUD of 45 days.
Not a beyond use date study, not potency over time study but a real stability study seeing what every component is getting degraded into and the percentages of each, container closure studies, sterility/fungal/endotoxin at time points…etc.
One recent story, the compounding pharmacy Imprimis that made curcumin in PEG 40 castor oil; they weren’t using USP grade and degraded (no stability study done on this obviously).
With the previous version there was quite a bit of confusion and they made reference to for direction.
That being said, the only TRUE way to extend dating is to do a stability study.
Wiele z tych kobiet to zdesperowane samotne mamuśki i zdradzające żony pragnące nieco zabawy. Czy zgadzasz się zachować tożsamość tych kobiet w tajemnicy?
The general guidelines for assigning beyond use dates have been laid out in USP chapter and will be changed with the revision that is coming.
We, myself included, historically have given 180 day beyond use dating to our products without a second thought and no real scientific data to back up that claim.
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Does it really make sense for us to have this kind of dating without any REAL data behind it?