Stability and sterility testing and dating

If you have multiple vial sizes for your product (10 and 30 m L vials) you may consider cutting that down to one; each of these would need to have it’s own stability study done because the containers are different and may affect the stability of the compound.If you have multiple strengths of the same product consider bracketing.The basic “need-to-know” is that you need to figure out if anything in the product will affect the assay for detecting your main ingredient (the API).And again, just to repeat the main point: you need to force the degradation of your product., 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.More importantly you can assure your patients that the product has the stability that’s claimed on the label with scientifically backed data.

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If you’ve had any chemistry classes you may remember chromatography (if you’re like me, nope! If not, check out this video from Kahn academy or this post (also from Kahn academy).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.Just like I stated above the reasoning for testing 3 lots; to validate each of these methodologies they need to be repeated multiple times in order to design a validated method.If you’re looking to perform a stability study on a single ingredient product for 6 month to 1 year dating the cost will more than likely be over ,000.

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