Stability and sterility testing and dating lesbisan girls dating site canada
More importantly you can assure your patients that the product has the stability that’s claimed on the label with scientifically backed data.The quicker we adopt this kind of mindset, the more legitimate we look.This is highly dependent on the lab you choose and which tests you select to perform at each time point.I’ve tried to lay out in simple terms the absolute minimum that’s required to claim and defend your beyond use dates against any board of pharmacy that may inspect your pharmacy., the long-standing concept of drug stability (beyond-use dates and expiration dates) came to the forefront of pharmacy compounding practice.Beyond-use date extension can only be done if end-point sterility testing is done on compounded sterile preparations.The point here is that you should think carefully about which tests to include at each time point while trying to minimize costs; unfortunately that’s a fine line to walk.
In addition, the lab will need to validate methodologies for testing endotoxin, potency and antimicrobial effectiveness (USP ).
Typically you’d perform testing at 0, 14, 30, 60, 90, 120, 180.
Using 30 day intervals (after day 30) would ensure that if you start to lose potency at day 90 and don’t make it to 120 you can stop the study at that point and you’d still be able to claim your dating for 90 days.
However, there are some good resources out there that point out exactly what criteria is necessary for a valid stability study (see references).
After all, if you’re going to put up the money for one of these it’d be nice to only have to do it once.