Stability and sterility testing and dating
It is not for everyone and can only be accomplished by using an analytical approach.
This article discusses the unique skill set required by pharmacists to accomplish and maintain these processes.
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.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.It’s recommended to do a minimum of 5 time points in any study to determine linearity. You may be able to do an initial and final for some of these.Some other components of a stability study may include: p H, potency, container closure integrity, particulate matter, sterility and endotoxin. However, keep in mind if any of the key factors fall out of spec (sterility, endotoxin, potency) you will not be able to claim the dating.
Typically you’d perform testing at 0, 14, 30, 60, 90, 120, 180.