The question in the title: What published stability data actually covers, and what it does not I will give what I have already checked below so nobody repeats it.
Reading back through what has been written here about published stability data actually covers, three questions come up every time and only one has ever been answered properly.
Listing all three, with what I think the state of the answer is for each, so the thread can start further along than the last one did.
Narrowing post #7, because the general version has more than one answer.
Adding what did not work for me on published stability data actually covers, since the failures never get written up and they are half the useful information.
The question underneath published stability data actually covers is usually "how would I tell?" rather than "what is true?", and that one has a method attached to it.
Write down what you would expect to see under each hypothesis before you collect anything. If they predict the same observation, collecting it will not help.
Saving this. It is the version I will quote when the question comes round again.
I want to gently push back on the reply above about storage extrapolation. The advice is sound and the confidence is not.
We are extrapolating from stability data on a licensed formulation to a preparation that differs in concentration, diluent and container. That extrapolation is reasonable and it is still an extrapolation. Saying so does not weaken the practical recommendation; it just stops the recommendation from hardening into a fact that someone cites as certain.
Door storage in a refrigerator is the warmest and most variable position in the appliance. A shelf at the back is a materially different environment.
I would want a second opinion before relying on that.
Visible particulate is a strong signal in the other direction: it is a reason to stop and ask rather than to filter and proceed.
Flagging that the sources on this are thinner than the confidence in the thread suggests.
Quietly grateful for the plain phrasing. Not every thread gets that.
Read the full topic (149 posts)
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